Analyte Measurement Devices and Systems, and Components and Methods Related Thereto

ABSTRACT

In some aspects, a modular analyte measurement system having a replaceable strip port module is provided to permit contaminated modules to be replaced. Some aspects of the present disclosure related to barriers for strip ports or the sealing of strip ports and/or analyte measurement devices to maintain a clean strip port and/or enable the strip port to be cleaned for reuse. Cleaning tools are also provided. Also provided are strip port interfaces that guide fluid away from the strip port opening, as well as absorptive elements that prevent fluid from entering a strip port. Analyte measurement devices with gravity sensors or accelerometers are also provided, along with methods related thereto. Also provided are docking station that serve as an information server and provides storage and recharging capabilities.

PRIORITY

This application claims the benefit of priority to U.S. ProvisionalPatent Application No. 61/406,860, filed Oct. 26, 2010, which is herebyincorporated by reference.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is related to U.S. patent application Ser. No.12/175,279, filed on Jul. 17, 2008. This application is also related toU.S. patent application Ser. No. 12/495,662, filed on Jun. 30, 2009, andSer. No. 12/624,231, filed on Nov. 23, 2009, both of which claimpriority to U.S. patent application Ser. No. 12/175,279. The disclosuresof the above-mentioned applications are incorporated herein by referencein their entirety.

BACKGROUND

One of the tools used in diabetes management is an analyte measurementdevice (or analyte meter). An analyte measurement device is typicallyused to measure the blood glucose level of a person based on a sample ofblood. The process of using an analyte measurement device is notcomplicated, and is often performed several times a day. First, a userinserts an analyte test strip into a strip port of the measurementdevice. The user then lances her finger to obtain a small sample ofblood. The blood sample is then placed onto the analyte test strip, andthe measurement device analyzes the blood sample. The measurement devicethen typically displays a blood glucose level from the analysis.

In order to ensure an accurate measurement is being generated, it isnecessary to keep the measurement device free from contamination. Thereare instances where the strip port may become contaminated with blood orother fluids (e.g., calibration fluid). When this occurs, theperformance of the measurement device suffers and the user is no longerassured an accurate result. As such, the user may need to purchase a newmeasurement device.

Dedicated hospital meters have high occurrence rates of contaminationdue to factors such as heavy use, need for calibration, and otherenvironmental factors. Contamination of a hospital meter, and thesubsequent need to replace the hospital meter, is costly. Further, theinventors have found that a substantial number of hospital meters arereturned to the manufacturer simply because the strip port has beencontaminated, while most of the other parts of the meter remain entirelyfunctional.

BRIEF SUMMARY

Presented herein is a modular analyte measurement system having areplaceable strip port module. Some aspects of the present disclosurerelate to modular components of the analyte measurement system. In oneembodiment, for example, there is provided a replaceable strip portmodule having a housing and an analyte test strip port disposed withinthe housing. The module is inserted within an opening in an analytemeter, and is thereafter removably attached to the meter. The analytetest strip port within the module is electrically coupled to the analytemeter. In the event that the analyte test strip port within the moduleis contaminated, the replaceable strip port module can be removed andexchanged for a new replaceable strip port module.

In some aspects of the present disclosure, an analyte measurement systemis provided that includes an analyte meter having a meter housing and aprocessing circuit disposed within the housing, and a replaceable stripport module. The replaceable strip port module has a module housing thatincludes a first aperture, which receives an analyte test strip, and aninterface aperture. The replaceable strip port module has an analytetest strip port disposed within the module housing, and has anelectrical interface coupled to the analyte test strip port within themodule housing and extending out of the housing through the interfaceaperture.

In one embodiment, the analyte measurement system includes an attachmentfeature to removably attach the replaceable strip port module to theanalyte meter.

In one embodiment, the module housing fits within an aperture in themeter housing.

In one embodiment, the module housing includes external alignmentfeatures to align the module housing within the aperture in the meterhousing.

In one embodiment, the meter housing includes alignment features toalign the module housing within the aperture in the meter housing.

In one embodiment, the electrical interface includes a plurality ofcontact pads to couple to SIM connectors within the meter housing.

In one embodiment, the electrical interface includes a plurality of pinsto couple to a pin header within the meter housing.

In one embodiment, the electrical interface includes an edge connectorto couple to a corresponding edge connector within the meter housing.

In some aspects of the present disclosure, a replaceable strip portmodule is provided for use in a modular analyte measurement system, andincludes a housing. The housing includes an open end and an interfaceaperture. The replaceable strip port module also includes an analytetest strip port disposed within the open end of the housing, and anelectrical interface coupled to the analyte test strip port within thehousing and positioned such that the electrical interface is exposed tothe exterior of the housing through the interface aperture, and a capcovering the open end of the housing. The cap includes an aperture sizedto receive an analyte test strip, and the aperture is aligned with theanalyte test strip port such that when an analyte test strip is insertedinto the aperture, the analyte test strip is inserted into the analytetest strip port.

In one embodiment, the housing further comprises internal alignmentfeatures to align the analyte test strip port within the housing.

In one embodiment, the housing comprises external alignment features toalign the replaceable strip port module within an analyte meter in theanalyte measurement system.

In one embodiment, the electrical interface includes a plurality ofcontact pads configured to couple to SIM connectors within an analytemeter.

In one embodiment, the electrical interface includes a plurality of pinsto couple to a pin header within an analyte meter.

In one embodiment, the electrical interface includes an edge connectorto couple with a corresponding edge connector within an analyte meter.

In one embodiment, the cap includes an indented region on a surface ofthe cap.

In one embodiment, a first cap gasket is provided as a seal between thecap and an analyte meter.

In one embodiment, a second cap gasket is provided as a seal between thecap and the housing.

In one embodiment, a single cap gasket is provided as a seal between thecap, the housing, and an analyte meter.

Some aspects of the present disclosure related to barriers for stripports or the sealing of strip ports and/or analyte measurement devicesto maintain the strip port and device free from fluids or othercontaminants, and/or to enable the strip ports and device to be cleanedor disinfected for reuse.

In one embodiment, a barrier device is coupled to a strip port toprovide for a contaminant free environment.

In another embodiment, the strip port is a replaceable strip port modulethat may be removably coupled to the analyte measurement device to becleaned and re-used, or disposed of after contamination.

In yet another embodiment, the strip port is internally sealed tocontain fluid within the strip port and prevent fluid from entering theremainder of the measurement device.

In yet another embodiment, the analyte measurement device is partiallyor completely sealed to enable the device to be cleaned with solutionand/or fully submerged in cleaning solution.

In yet another embodiment, a flow through port is provided that permitssolution to flow through the strip port and device to an outlet wherethe solution is drained out.

In some aspects of the present disclosure, a cleaning tool is providedfor cleaning of a strip port of an analyte measurement device. Thecleaning tool includes a handle and an end shaped like a test strip toenable the end to fit within a test strip port for cleaning.

In some aspects of the present disclosure, a strip port interface isprovided to guide fluid away from the strip port opening of the stripport of the analyte measurement device.

In one embodiment, the strip port interface provides wicking capillariesvia alternative paths that guide the fluid away from the strip portopening. In another embodiment, the strip port interface includes anarrow groove to guide fluid to a reservoir positioned away from thestrip port opening.

In yet another embodiment, the strip port interface includes anabsorbent insert that contacts or is positioned adjacent to an insertedtest strip to absorb any fluid on the test strip and prevent the fluidfrom entering the strip port.

In some aspects of the present disclosure, absorptive elements areprovided at the strip port to absorb any fluid and prevent the fluidfrom entering the strip port. In one embodiment, the absorptive elementscouple to the strip port. In another embodiment, the absorptive elementsare part of an absorptive guard that is coupled to the strip port.

In some aspects of the present disclosure, an analyte measurement deviceis provided that includes a gravity sensor or accelerometer to detectthe orientation of the device and determine if the device is in animproper orientation to perform a control test solution. Methods relatedthereto are also provided.

In some aspects of the present disclosure, docking stations areprovided. In one embodiment, the docking station serves as aninformation server for “docking” an analyte measurement device such, asa glucose meter, and also provides storage and recharging capabilitiesfor spare batteries, such as standard batteries that can be recharged.

BRIEF DESCRIPTION OF THE FIGURES

The accompanying drawings, which are incorporated herein, form part ofthe specification. Together with this written description, the drawingsfurther serve to explain the principles of, and to enable a personskilled in the relevant art(s), to make and use the present invention.

FIG. 1 illustrates a view of a measurement device including a stripconnector that makes the strip interface cleanable.

FIG. 2 illustrates a perspective view of a measurement device with astrip connector.

FIG. 3 illustrates one embodiment of contacts included in a stripconnector.

FIG. 4 illustrates another embodiment of contacts included in a stripconnector.

FIG. 5 illustrates another embodiment of contacts included in a stripconnector.

FIG. 6 illustrates a device with spring arm connectors connected with atest strip.

FIG. 7 illustrates a top view of a device with contacts that iselectrically connected with a test strip.

FIG. 8 illustrates another embodiment of a device with pin contacts thatinterface with corresponding sockets on a test strip.

FIG. 9 illustrates a top view of pin contacts in a strip connector.

FIG. 10 illustrates a perspective view of a device that uses adisposable strip port.

FIG. 11 illustrates a side view of an end of the device including theelectrical interface that receives the disposable port.

FIG. 12 illustrates a top view of a disposable port that interfaces witha device and with a test strip.

FIG. 13 is a perspective view of a disposable port that includes aseparable portions such that one portion interfaces with the measurementdevice and another portion interfaces with a test strip.

FIG. 14 illustrates a perspective view of one embodiment of a portion ofthe disposable port that provides an electrical interface for a teststrip.

FIG. 15 illustrates an end view of the disposable port including thetest strip interface.

FIG. 16 illustrates electrical connections between the device and thetest strip through the disposable port.

FIGS. 17A and 17B illustrate additional structure for associating thestrip port with a measurement device.

FIG. 18 is a front-side perspective view of a replaceable strip portmodule in accordance with one embodiment presented herein.

FIG. 19 is a back-side perspective view of the replaceable strip portmodule of FIG. 18.

FIG. 20 is an exploded view of the replaceable strip port module of FIG.18, showing the internal components of the replaceable strip portmodule.

FIG. 21 is a side view of the replaceable strip port module of FIG. 18.

FIG. 22 is a plan view of the replaceable strip port module of FIG. 18.

FIG. 23 is a perspective view of a modular analyte measurement system inaccordance with one embodiment presented herein.

FIG. 24 is a plan view of the embodiment shown in FIG. 23.

FIG. 25 is a side view of the embodiment shown in FIG. 23.

FIG. 26 is a view of the embodiment shown in FIG. 23, having thereplaceable strip port module inserted into the analyte meter.

FIG. 27 is a side view of the embodiment shown in FIG. 26.

FIG. 28 is a front-side view of the embodiment shown in FIG. 26.

FIGS. 29A and 29B illustrate perspective and side views, respectively,of a pin-header connector form.

FIG. 30 illustrates a side views of an edge connector form.

FIG. 31 illustrates a side views of an alternative connector form.

FIG. 32 illustrates the replaceable strip port module of FIG. 31.

FIG. 33 is an exploded view of a replaceable strip port module, inaccordance with another embodiment presented herein.

FIGS. 34A-34D illustrate an analyte measurement system in accordancewith one embodiment presented herein.

FIGS. 35A-35D illustrate an analyte measurement system in accordancewith another embodiment presented herein.

FIGS. 36A-36D are assembly drawings of an analyte measurement system inaccordance with an embodiment presented herein.

FIG. 37A illustrates a barrier, in accordance with an embodimentpresented herein.

FIG. 37B illustrates a side view of the barrier device and strip portshown in FIG. 37A.

FIG. 37C, which illustrates a front view of a strip port having fourbarriers, according to one embodiment.

FIG. 38 illustrates a replaceable strip port module, in accordance withan embodiment presented herein.

FIG. 39 illustrates a meter including a strip port that includes a sealand gasket, in accordance with an embodiment presented herein.

FIG. 40 illustrates fluid flowing off an analyte measurement device,according to one embodiment.

FIGS. 41A-B illustrate a sealed port that permits solution to flowthrough the strip port, according to two different embodiments.

FIG. 42 illustrates a sealed analyte measurement device submerged influid, in accordance with an embodiment presented herein.

FIG. 43 illustrates a cleaning tool for a strip port of analytemeasurement device, in accordance with an embodiment presented herein.

FIGS. 44A-C illustrate a fluid wicking interface, in accordance with anembodiment presented herein.

FIGS. 45A-C illustrate a fluid wicking interface, in accordance with anembodiment presented herein.

FIGS. 46A-C illustrate a fluid wicking interface, in accordance with anembodiment presented herein.

FIGS. 47A-D illustrates a test strip at various points when beinginserted into a strip port having an absorptive guard coupled thereto,in accordance with an embodiment presented herein.

FIGS. 48A-B illustrate an analyte measurement device including a gravitysensor or accelerometer, in accordance with an embodiment presentedherein.

FIGS. 49A-B illustrate a docking station, in accordance with anembodiment presented herein.

FIG. 49C illustrates a removable charging module, in accordance with anembodiment presented herein.

DETAILED DESCRIPTION

Before the embodiments of the present disclosure are described, it is tobe understood that this invention is not limited to particularembodiments described, as such may, of course, vary. It is also to beunderstood that the terminology used herein is for the purpose ofdescribing particular embodiments only, and is not intended to belimiting, since the scope of the embodiments of the invention will belimited only by the appended claims.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimits of that range is also specifically disclosed. Each smaller rangebetween any stated value or intervening value in a stated range and anyother stated or intervening value in that stated range is encompassedwithin the invention. The upper and lower limits of these smaller rangesmay independently be included or excluded in the range, and each rangewhere either, neither or both limits are included in the smaller rangesis also encompassed within the invention, subject to any specificallyexcluded limit in the stated range. Where the stated range includes oneor both of the limits, ranges excluding either or both of those includedlimits are also included in the invention.

In the description of the invention herein, it will be understood that aword appearing in the singular encompasses its plural counterpart, and aword appearing in the plural encompasses its singular counterpart,unless implicitly or explicitly understood or stated otherwise. Merelyby way of example, reference to “an” or “the” “analyte” encompasses asingle analyte, as well as a combination and/or mixture of two or moredifferent analytes, reference to “a” or “the” “concentration value”encompasses a single concentration value, as well as two or moreconcentration values, and the like, unless implicitly or explicitlyunderstood or stated otherwise. Further, it will be understood that forany given component described herein, any of the possible candidates oralternatives listed for that component, may generally be usedindividually or in combination with one another, unless implicitly orexplicitly understood or stated otherwise. Additionally, it will beunderstood that any list of such candidates or alternatives, is merelyillustrative, not limiting, unless implicitly or explicitly understoodor stated otherwise.

Various terms are described below to facilitate an understanding of theinvention. It will be understood that a corresponding description ofthese various terms applies to corresponding linguistic or grammaticalvariations or forms of these various terms. It will also be understoodthat the invention is not limited to the terminology used herein, or thedescriptions thereof, for the description of particular embodiments.Merely by way of example, the invention is not limited to particularanalytes, bodily or tissue fluids, blood or capillary blood, or sensorconstructs or usages, unless implicitly or explicitly understood orstated otherwise, as such may vary.

The publications discussed herein are provided solely for theirdisclosure prior to the filing date of the application. Nothing hereinis to be construed as an admission that the embodiments of the inventionare not entitled to antedate such publication by virtue of priorinvention. Further, the dates of publication provided may be differentfrom the actual publication dates which may need to be independentlyconfirmed.

The following detailed description of the figures refers to theaccompanying drawings that illustrate an exemplary embodiment of ananalyte measurement system. Other embodiments are possible.Modifications may be made to the embodiment described herein withoutdeparting from the spirit and scope of the present invention. Therefore,the following detailed description is not meant to be limiting.

Certain embodiments presented herein relate to electrical interfaces inmeasurement devices. Measurement devices often have electricalinterfaces that allow them to electrically connect with another deviceor apparatus and perform an analysis of an analyte. A device thatmeasures blood glucose levels, for example, includes electricalinterfaces that allow the device to measure the blood glucose level froma small blood sample.

Embodiments presented herein also relate to systems and methods that canimprove the mean time before failure (MTBF) in measurement devices. Byimproving the MTBF, a user is provided with a device that lasts longerand has more accurate performance over time.

Embodiments presented herein also relate to strip connectors or stripports that can be cleaned and/or replaced. The ability to clean orreplace a strip port can prevent the device from experiencing problemsoften associated with port contamination. Blood and other contaminants,for example, can often contaminate a port and make the device unusableor result in inaccurate analysis. A port that can be cleaned or replacedwithout affecting the operation of the device thus increases the MTBF.

One embodiment thus relates to an insert molded strip connectorconfiguration that prevents the ingress of liquid or other contaminant.The molded strip connector can be corrosion resistant, washable, waterproof, dust proof, and highly electrically conductive. In anotherembodiment the port, or at least a portion of the port, is disposable. Adisposable port allows the device to adapt to different test strip formfactors by selecting the appropriate port replacement and also allowsthe device to continue to function when the port is contaminated bysimply replacing the contaminated port.

FIG. 1 illustrates a top view of one embodiment of a measurement deviceused to analyze a sample of blood. The measurement device 100 typicallyincludes a display 102 and a user interface 104. The display 102 can beused to provide instructions or results to the user related to themeasurement of the blood glucose level in a sample of blood. The userinterface 104 allows a user to perform various functions, includingstarting the analysis, turning the device on/off, and the like.

FIGS. 1 and 2 also illustrate an example of a strip connector 110. Thestrip connector 110, in this example, includes a plurality of contacts112. The contacts 112 provide a physical and/or electrical interface toan appropriately configured test strip or test strip module. In thisexample, the case 108 of the device 100 may be molded around thecontacts 112. By molding the case 108 of the device 110 around thecontacts, the interface between the case 108 and the contacts 112becomes impervious to contamination, including liquid contamination(e.g., water, blood, etc.). The interface between the case 108 and thecontacts 112 then becomes waterproof or at least sufficiently waterproofto allow the device 100, or at least the strip connector 110, to bewashed. The ability to wash the device 100, or at least the stripconnector 110, makes the device 100 substantially or completelycorrosion resistant, washable, waterproof and dustproof. Contaminantscan be removed or cleaned from the device without affecting the device100.

The contacts 112 are usually conductive and may be gold plated toimprove the conductivity of the contacts 112. The contacts 112 may alsobe formed of high strength steel to protect the contacts, which areexposed and extend out of the case 108 of the device 100. In otherembodiments, the contacts may be formed from impregnated polymers,beryllium copper, phosphor bronze, titanium, nickel plated, tin platedor any combination thereof. In alternative embodiments, the contacts maybe any material that provides the proper conductivity where necessary.

The contacts 112 can be arranged in a plurality of differentconfigurations. The contacts can be arranged in one or more rows and/orcolumns on the surface 120. The contacts 112 can be arranged to connectwith different sides of the printed circuit board (or other connector)inside the device 100. Further, the contacts 112 can be bent or shapedto connect with a test strip and provide the electrical and/ormechanical connection between the device 100 and the test strip. Asdiscussed more fully herein the device 100 can be configured withvarious types of contacts that permit the device to interface with teststrips of different form factors. In addition, other structures mayextend out of the surface 120 to provide mechanical structure to securethe test strip.

FIG. 3 illustrates a side view of a device 100 including the strip port110. In this example, the strip port 110 extends out of the device 100through the surface 120 and the interface between the surface 120 andthe contacts 112 is sealed or substantially sealed to prevent ingress ofliquid or other contaminant. The contacts 112 typically pass through thesurface 120 of the device 100 and include a connector 114 to the printedcircuit board 106. The connector 114 may be a bond wire or otherconnection to form a conductive path between the printed circuit board106 and the contacts 112. The contacts 112, in this embodiment, are pintype contacts.

FIGS. 4 and 5 illustrate additional embodiments of the contacts 112.FIG. 4 illustrates a clip pin 114 while the contact depicted in FIG. 5is a spring arm 116. Each type of contact 112 enables physical and/orelectrical contact with a corresponding test strip in a different wayand may accommodate different form factors. In each example, thecontacts 112 pass through the surface 120 of the device 100 andelectrically connect with a printed circuit board or other circuitryinside the device. The surface 120 has been formed around the contacts112 to provide a barrier that allows the contacts 112 to be cleaned orwashed.

FIG. 6 illustrates a side view of the device 100 connected with a teststrip 150. In this example, the device 100 includes spring arms 116 thatextend out of the surface 120. When the strip 150 is inserted into thespring arms 116, the spring arms 116 may separate and exert a forcetowards the test strip 150 to hold the test strip in place physicallyand to provide an electrical connection between the spring arms 116 andthe test strip 150. In FIG. 6, the portion 118 of the spring arms 116inside the device 100 connect with the printed circuit board 106 on bothsides in this example, although there is no requirement that eachportion of each of the spring arms 116 or of the contacts in general beused to establish an electrical connection.

The case 108 of the device 100 has been formed, such as by injectionmolding, to form a surface 120 that encloses the portion 118 of thespring arms 116 (or other contact) inside of the device 100 whileexposing the external portion of the spring arms 116 (or other contact).As a result, the interface between the spring arms 116 and the surface120 is sealed or substantially sealed to prevent ingress of liquid suchas blood or other contaminant from entering the device 100 andinterfering with the operation or functionality of the device 100. As aresult of this interface, the spring arms 116 or other contact can bewashed or cleaned in the event of contamination or for any other reasonwithout interfering with the operation of the device 100.

FIG. 7 illustrates a top view of the device 100 illustrated in FIG. 6.In this example, the spring arms 116 extend out of the surface 120 andare connected to the test strip 150. A blood sample 156 is loaded on thetest strip and contacts 156 and 158 are in contact with the spring arms116. In this example, the contact 158 is on one side of the test strip150 while the contact 156 is on the other side of the test strip 150.The spring arm configuration illustrated in FIG. 7 enable contacts 158and 156 of the test strip 150 to be on either side of the test strip. Insome instances, some of the spring arms 116 may not be in electricalcontact with the test strip 150.

FIG. 8 depicts a perspective view of another embodiment of a moldedstrip connector. In this example, the device 100 includes pin contacts112 that pass through a surface 120 of the device 100. At least some ofthe pin contacts 112 encased or enclosed within the case 108 of thedevice 100 are electrically connected to the printed circuit board 106.Because the contact pins 112 can be arranged in various configurations,such as rows and columns, the pin contacts 112 can connect to both sidesof the printed circuit board 106.

The test strip 160 illustrated in FIG. 8 includes sockets 162 that areshaped and configured to cooperate with the pin contacts 112 toestablish at least an electrical connection, but may also providephysical stability to the connection between the test strip 160 and thedevice 100. The sockets 162 are mounted in a connection module 164 thatroutes the electrical connection of the sockets 162 to the strip 160such that the device 100 can analyze any analyte located thereon.

FIG. 9 illustrates a top view a device with a test strip port. FIG. 9illustrates that the contacts 112 can be inserted into the sockets 162to form a connection between the device 100 and the test strip 160. Whena sample is loaded in the space 166, the connection established betweenthe device 100 and the test strip 160 via the pin contact/socketconnection, the sample can be analyzed.

Another embodiment of the present disclosure relates to a disposablestrip port. A disposable strip port enables the port or a portionthereof to be exchanged, by way of example and not limitation, foranother port or portion thereof when the current port or portion thereofmalfunctions or is contaminated. FIG. 10 illustrates a perspective viewof a measurement device 200. The device 200 includes a display 202 and auser interface similar to the display and user interface illustrated inFIG. 1. The display 202 may be used to convey information includingresults (such as blood glucose level) on an analysis of an analyte suchas a blood sample.

The device 200 includes a port 208 that is inset in a receptacle 206formed in the device 200. The receptacle 206 can be configured toreceive a disposable or replaceable port 250. As illustrated in FIG. 10,the disposable port 250 can be inserted into the receptacle 206 andconnected both physically and electrically with the device 200 throughthe port 208. The disposable port 250 includes a strip port 252 that isconfigured to receive the test strip 150. When the port 250 is insertedinto the receptacle 206, the surface with the port 252 is often flushwith the surface 214, although other configurations are possible withrespect to the position of the port 250 relative to the device 200.

FIG. 11 illustrates a view of an end of the device 200. FIG. 11illustrates that port 208 and the printed circuit board 212 (or othersuitable interface) are disposed therein at the end of the receptacle206. The printed circuit board 212 may have traces 216 or other contactson either side of the printed circuit board 212.

FIG. 12 illustrates a top view of the device 200, the port 250, and atest strip 150. In this example, the port 208 provides access to thecontacts 216 of the printed circuit board 212. The port 250 alsoincludes corresponding contacts 254 that are configured to connect withthe traces 216. The contacts 254 may be spring arms, pins, and the likeor any combination thereof. Further, the port 208 may be insert moldedas previously described to provide an interface that is substantiallyimpervious to contaminants. In this case, the port may be changeable toallow the device 200 to adapt to different form factors or to provideother functions according to the configuration of the port 250.

In this example, the port 250 also has a strip receptacle 260 (anexample of the strip port 252) or strip port disposed on a side oppositethe contacts 254, although the receptacle can be repositioned on anyside of the port 250. The test strip 150 may be inserted into thereceptacle 260 and a sample of the test strip 150 may be analyzed whenthe port 250 is connected to the port 208.

The port 250 in this example may include a first portion 256 and asecond portion 258. The portion 256 and the portion 258 can be oneintegrated port or may include portions that can be repeatedly separatedand connected. As previously mentioned, the portion 258 can be replacewith differently configured portions to provide a receptacle 260 thataccommodates different test strip form factors.

The portion 256 may be configured to interface with the device 200 viathe port 208. The portion 256 may also include retention tabs 262 thatinteract with corresponding connectors 264 to connect at least theportion 256 with the device 200 physically. In one example, the portion256 may permanently connect with the device 200, while allowing theportion 258 to be disposable. Advantageously, a user can selectdifferently configured portions 258 to adapt to different configurationsof the test strips. This may allow a user not only to replace the port250 or a portion thereof, but also utilize test strips of different formfactors.

FIG. 13 illustrates a perspective view of one embodiment of a disposableport 250. In this example, the port 250 includes a portion 258 that isconfigured to interface with test strips and a portion 253 that isconfigured to interface with a measurement device 200. The portion 256includes spring arms 254 that are configured to connect with traces on aprinted circuit board as previously disclosed. Alternatively, theportion 256 may include pin contacts or other contacts that interfacewith corresponding structure on the port 208 of the device 200 toestablish the requisite connection.

The portion 256, in this example, includes a retention tab 262 thatenables the port 250 to connect with the device 200 in a permanent orsemi-permanent fashion. When connected to the device 200, the tab 262keeps the portion 256 in place while the portion 258 can be separatedfrom the portion 256 and replaced with a new portion or simply cleaned.As previously noted, the portion 258 can have multiple configurations toenable connectivity with different test strip form factors.

The port 250 includes a guide member 264, in this embodiment, thatinteracts with corresponding rail structure on the device 200 tofacilitate insertion of the port 250 onto the device 200. Thecooperation of the guide member 264 and the rail structure can ensurethat the port 250 is properly aligned with the port 208 during insertionand can also prevent damage to the contacts during both insertion and/orremoval of the port 250. This can prevent damage to the spring arms 254and ensure that a proper connection is made between the port and thedevice.

FIG. 14 illustrates a perspective view of one embodiment of the portion258. The portion 258 includes pins 266 that are used to connect withcorresponding structure in the portion 256. The pins 266 may provide afriction fit with the corresponding structure to retain the connectionbetween the portion 256 and the portion 258.

FIG. 15 illustrates a view of a test port or receptacle 260 of theportion 258. In this example, the portion 258 includes a receptacle 260configured to receive a test strip. Contacts 270 are disposed inside theport and arranged to make at least electrical contact with the teststrip in order to allow analysis of the blood sample on the strip.

FIG. 16 depicts a side view the device 200 with a disposable port 250connected thereto. FIG. 16 illustrates the spring arms 264 inside of theportion 256. On the device side, the spring arms extend out of the port250 and make contact with the printed circuit board 212 inside thedevice 200. The opposite end of the spring arms 264 form sockets 272.The sockets 272 are configured to receive and electrically connect withthe pins 266 that extend out of the portion 258. The pins 266 alsoinclude contacts 270 (illustrated as spring arms in this example) insideof the portion 258 that are configured to electrically connect with atest strip 150 when the test strip inserted in the receptacle or port260.

As previously stated, the portion 258 can be configured to adapt tomultiple strip form factors. As a result, the portion 258 may alsoinclude contacts 270 that are configured as pins, plugs, sockets, clips,and the like or any combination thereof. The interface between theportion 256 and 258 allows at least the portion 256 to be replaceablewhenever it begins to fail or is contaminated or for any other reason.Further, the electrical connections between the device 200, the portion256, the portion 258, and the test strip 150 can take various formsincluding, but not limited to, pin contacts, clip pins, spring arms, andthe like or any combination thereof. In this example, the contacts orpins illustrated for the portions 256 and 258 cooperate to establishelectrical connections.

FIGS. 17A-B illustrates examples of the connections or associationsbetween the port 250 and the device 200. FIG. 17A illustrates that theconnection between the port and the device may include a latch 282 thatinterfaces with a receptacle 280 to secure the portion 256 to the device200. The receptacle 280 and latch 282 cooperate to provide a connection.A release 284 may also be included in the device 200 that releases thelatch 282 from the receptacle 280. As a result, the connectionillustrated in FIG. 17A can be permanent or semi-permanent.

FIG. 17B illustrates another interface or connection between the device200 and the port 250. In this example, the device may include sockets286 that have an opening adapted to receive the ball 288 connected tothe port 250. The ball 288, when snapped into the socket 286, expandsthe socket 286 to allow the ball 288 to enter the socket 286. Once theball is inserted, the socket contracts to establish the connection. As aresult, a force is required to insert the ball 288 into the socket. Asimilar force may be required to release the connection illustrated inFIG. 17B. In these examples, the connection may be semi-permanent andensures that the electrical connection is maintained.

In other embodiments, the connection between the port 250 and the device200 (or between the contact pins 266 and sockets 272) may include apress fit or a friction fit. For instance, the port 250 may be slightlywider than the receptacle 206. As the port 250 is inserted into thereceptacle 206, the friction between the port 250 and the device 200maintains the port in the proper position.

In other embodiments, the electrical connections can also provide themechanical connection. For example, a friction fit between the pins 266and the sockets 272 may provide sufficient force to keep the portions256 and 258 connected. A user, however, can remove the portion 256 andreplace it.

FIGS. 18-22 provide various views of a replaceable strip port module1800, in accordance with another embodiment presented herein. Forexample, FIG. 18 is a front-side perspective view of replaceable stripport module 1800. FIG. 19 is a back-side perspective view of replaceablestrip port module 1800. FIG. 20 is an exploded view of replaceable stripport module 1800. FIG. 21 is a side view of replaceable strip portmodule 1800. FIG. 22 is a plan view of replaceable strip port module1800.

As shown in FIGS. 18-22, replaceable strip port module 1800 includes ahousing 1810 with a cap 1815. An analyte test strip port 2000 isdisposed within an open end of housing 1810, which is then enclosed (orcovered) by cap 1815. In one embodiment, analyte test strip port 2000 isan electro-chemical strip port. In an alternative embodiment, analytetest strip port 2000 is an optical strip port. As shown in FIG. 20,analyte test strip port 2000 is coupled to a printed circuit board (PCB)1820, and electrical leads of analyte test strip port 2000 areelectrically coupled to one or more contact pads 1822 on PCB 1820.Housing 1810 includes an interface portion (or interface aperture) 1813to expose contact pads 1822 when analyte test strip port 2000 and PCB1820 are inserted and aligned within housing 1810. In one embodiment, aseal member may be provided along the edge of interface aperture 1813 toprovide a fluid tight seal between PCB 1820 and housing 1810.

In one embodiment, housing 1810 is formed of a plastic mold, and morepreferably an anti-microbial plastic mold. In alternative embodiments,housing 1810 may be formed of other suitable materials such as rubbers,polymers, or thermally conductive materials. In one embodiment, forexample, housing 1810 and internal components is formed of medical gradePC/ABS plastic blend, and may include an anti-microbial plastic such asBAYER BAYBLEND AM120FR. In the embodiment shown in FIG. 20, housing 1810includes internal alignment features, such as internal alignment baffles2011 and internal alignment grooves 2012, to properly align analyte teststrip port 2000 and PCB 1820 within housing 1810. Such internalalignment features, and structures equivalent thereto, serve as meansfor aligning an analyte test strip port within the module housing. Ascrew hole 2013 is provided in housing 1810 to attach replaceable stripport module 1800 to an analyte meter, as further discussed below. Ascrew for use in screw hole 2013 may be a stainless steel, pan headPhilips, thread-forming screw.

Housing 1810 also includes external alignment features or guides 1811and beveled surfaces 2111 to further support the proper insertion andalignment of replaceable strip port module 1800 within an analyte meter.Such external alignment features, and structures equivalent thereto,serve as means for aligning a replaceable strip port module within ananalyte meter.

Cap 1815 serves to fully encase analyte test strip port 2000 withinhousing 1810. In one embodiment, cap 1815 is permanently attached tohousing 1810 with a hermetic seal 1916. In an alternative embodiment,cap 1815 may be removably attached to housing 1810. In anotheralternative embodiment, a gasket means (e.g., a rubber o-ring, fabric,etc.) may be used to seal the gap between cap 1815 and housing 1810. Inthe embodiment shown, cap 1815 also includes an optional tab extension1830 to facilitate in the insertion and removal of replaceable stripport module 1800 from an analyte meter.

Cap 1815 further includes an aperture 1817, which provides access toanalyte test strip port 2000. In operation, an analyte test strip isinserted through aperture 1817 and into analyte test strip port 2000. Inone embodiment, aperture 1817 provides sufficient clearance to accept awide variety of different analyte test strips form factors. In analternative embodiment, aperture 1817 may be customized to receive aspecific analyte test strip form factor. Customizing the aperture sizeor shape to a specific analyte test strip form factor can prevent theuse of non-matching or incompatible analyte test strips with analytetest strip port 2000. Aperture 1817 may also be formed with a one-wayvalve or port protector to swipe across the surface of an analyte teststrip when the analyte test strip is passed through aperture 1817. Suchan embodiment may be used to protect analyte test strip port 2000 fromunwanted contaminants. In alternative embodiments, aperture 1817 mayincorporate one or more port protectors, such as disclosed in U.S.Patent Application Publication No. 2009/0270696, which is incorporatedby reference herein in its entirety.

FIGS. 23-28 illustrate a modular analyte measurement system 2300,including a replaceable strip port module, such as replaceable stripport module 1800, and an analyte meter 2301. For example, FIGS. 23-25are perspective, plan, and side views, respectively, of system 2300prior to insertion of replaceable strip port module 1800 into analytemeter 2301. FIGS. 26-28 are perspective, side, and front views,respectively, of system 2300 having replaceable strip port module 1800inserted into analyte meter 2301.

Analyte meter 2301 may be similar to analyte meters known in the art.For example, analyte meter 2301 may include similar structures,functions, and components as the analyte meters described in U.S. Pat.No. 7,077,328, which is incorporated herein by reference in itsentirety. As shown, analyte meter 2301 includes a display panel 2302 fordisplaying instructions and/or results from an analyte measurement, anda user interface 2303 (not shown in FIGS. 24-28) for inputting commandsto the analyte meter. Analyte meter 2301 also includes internalprocessing units (not shown) for the analysis of a blood sample. Assuch, analyte meter 2301 includes means for analyzing an electricalsignal received from an analyte strip port. Analyte meter 2301, however,has been modified to lack a fully integrated analyte test strip port.Instead, analyte meter 2301 provides an open electrical interface withelectrical contacts corresponding to the electrical contacts of atypical analyte test strip port. Such open electrical interface coupleswith the exposed contact pads 1822 of replaceable strip port module 1800to complete analyte measurement system 2300.

For example, as shown in FIG. 23, analyte meter 2301 includes areceptacle 2310 that provides an opening in the analyte meter housing.Replaceable strip port module 1800 is designed to fit within receptacle2310. Guide features 2311 are provided in the meter housing to aide inthe insertion and alignment of replaceable strip port module 1800 withinreceptacle 2310. Analyte meter 2301 also includes a screw hole 2313,which aligns with screw hole 2013 in replaceable strip port module 1800.As such, replaceable strip port module 1800 can be removably attached toanalyte meter 2301 with a screw 2813 (see FIG. 28). Alternativeattachment means may also be employed to removably (or semi-permanently)attach replaceable strip port module 1800 to analyte meter 2301. Screwholes 2013 and 2313, and screw 2813, as well as equivalent structures,thereby serve as means for removably attaching the replaceable stripport module to the analyte meter. In one embodiment, for example, themeter housing and internal components is formed of medical grade PC/ABSplastic blend, and may include an anti-microbial plastic such as BAYERBAYBLEND AM120FR. In one embodiment, meter housing is formed of two ormore separate components, which are screwed together using M3 stainlesssteel screws. Such screws may have heads that differentiate them fromthe strip port retaining screws. For example, such screws may have Torxheads. Internal screws may be M2.5 zinc-plated, pan head Philips screws.

In operation, contact pads 1822 couple to corresponding open electricalconnections (not shown) inside of analyte meter 2301. In one embodiment,the open electrical connections are SIM connections that areelectrically coupled to a PCB within analyte meter 2301. In oneembodiment, any or all contact pads 1822 or connectors include gold orgold-plating. As such, electrical communication can be provided betweenanalyte test strip port 2000 and analyte meter 2301. In alternativeembodiments, the connection between replaceable strip port module 1800and analyte meter 2301 may be in the form of edge connectors, pinheaders, compression connectors, or other equivalent connectors. Suchconnector forms, and structure equivalent thereto, serve as anelectrical interface or means for electrically coupling the analyte teststrip port to the analyte meter.

FIGS. 29-32 illustrate alternative connector forms. FIGS. 29A and 29B,for example, illustrate perspective and side views, respectively, of apin-header connector form. In the embodiment shown, a replaceable stripport module 2900 is electrically coupled to a header 2950 in an analytemeter. Pins 2910, which are electrically coupled to leads in an analytetest strip port within replaceable strip port module 2900, areconfigured to mate with header ports 2960. Electrical current can thenflow from header 2950 to PCB 2990 through contacts 2970.

FIG. 30 illustrates a side views of an edge connector form. In theembodiment shown, a replaceable strip port module 3000 is electricallycoupled to an edge connector 3050 in an analyte meter. Pins 3010, whichare electrically coupled to leads in an analyte test strip port withinreplaceable strip port module 3000, are tail-wrapped and configured tomate with edge connector input contacts 3060. Electrical current canthen flow from edge connector 3050 to PCB 3090 through contacts 3070.

FIG. 31 illustrates a side views of an alternative connector form. Inthe embodiment shown, a replaceable strip port module 3100 iselectrically coupled to a connector 3150 in an analyte meter. A solderedwire 3110 is used to electrically couple leads in an analyte test stripport within replaceable strip port module 3100 to connector 3150. A heatsink 3175 is used for thermal control of wire 3110. Electrical currentcan then flow from connector 3150 to PCB 3190 through contacts 3170. Arubber gasket 3165 is used to align and replaceable strip port module3100 to the meter housing.

FIG. 32 illustrates the replaceable strip port module 3100 of FIG. 31,installed within a meter housing 3201. As shown in FIG. 32, rubbergasket 3165 aligns and maintains replaceable strip port module 3100 inplace. A rubber gasket 3265 is also employed to further align andmaintain replaceable strip port module 3100 in place. As shown in FIG.32, wire 3110 is looped during installation. Wire 3110 is provided withsuch additional length to provide flexibility and functionality to thesystem. In the event that a user wishes to perform an analyte test at adistance from the meter, replaceable strip port module 3100 may bewithdrawn from housing 3201 and an analyte test may be performed whilethe module and meter remain connected through wire 3110.

A common analyte strip port requires three functional leads forconnection with a meter. In the embodiment shown in FIGS. 18-28, analytetest strip port 2000 provides a line-for-line connection with three ofthe twelve contact pads 1822. The additional nine contact pads ofreplaceable strip port module 1800 allow for customization of system2300. For example, in one embodiment, a replaceable strip port modulehaving a glucose test strip port may be used to measure the user'sglucose levels. Such embodiment could employ contact pads 1, 2, and 3,as functional contacts, and contact pads 4 and 5 as identification leadsto identify the module to the meter as a glucose module. The replaceablestrip port module with the glucose test strip port may then be replacedwith a replaceable strip port module having a ketone test strip port tomeasure the user's ketone levels. Such a ketone module may use contactpads 6, 7, and 8, as functional contacts, and contact pads 9 and 10 asidentification leads to identify the module to the meter as a ketonemodule. Such customization adds to the functionality of system 2300.

In the event that unwanted fluids and contaminants enter throughaperture 1817 and comprise the function of analyte test strip port 2000,replaceable strip port module 1800 can be removed and replaced with anew replaceable strip port module. The replacement of replaceable stripport module 1800 can be done without discarding or replacing any of thefunctioning components of analyte meter 2301. As such, auser/manufacturer can save money by only replacing the components of thesystem 2300 that have actually been comprised.

FIG. 33 is an exploded view of a replaceable strip port module, inaccordance with another embodiment presented herein. The replaceablestrip port module of FIG. 33 is similar to the replaceable strip portmodule 1800 of FIG. 20, and includes a housing 3310, PCB 3320 withrespective strip port, and cap 3315. However, the replaceable strip portmodule of FIG. 33 also includes a gasket 3390. Further, cap 3315 differsfrom cap 1815 in that cap 3315 includes an indented region 3316 on asurface of the cap, which may facilitate entry and/or alignment of atest strip therein.

In operation, gasket 3390 sits within housing 3310 and serves as aholder, alignment element, and/or seal for PCB 3320. For example, gasket3390 may be sized to provide a fluid tight seal around PCB 3320. Gasket3390 may also be sized and configured to swipe across a surface of PCB3320 so as to clean a surface of PCB 3320 when the PCB is insertedthrough the gasket. Gasket 3390 may also be sized to provide a press-fitengagement with the interior surfaces of housing 3310.

In one embodiment, a cap gasket (not shown) is provided as a sealbetween cap 3315 and the meter housing. Further, a second cap gasket(not shown) may be provided as a seal between cap 3315 and strip portmodule housing 3310. In yet another embodiment, a single cap gasket (notshown) may be provided as a seal between cap 3315 and strip port modulehousing 3310 and the meter housing.

FIGS. 34A-34D illustrate an analyte measurement system in accordancewith one embodiment presented herein. The views presented in FIGS.34A-34D show the ornamental designs of an analyte measurement systemembodiment.

FIGS. 35A-35D illustrate an analyte measurement system in accordancewith yet another embodiment presented herein. The views presented inFIGS. 34A-34D show the ornamental designs of another analyte measurementsystem embodiment.

FIGS. 36A-36D are assembly drawings of an analyte measurement system inaccordance with an embodiment presented herein. As shown in FIG. 36A theanalyte measurement system includes an upper housing component 3601U anda bottom housing component 3601B. A membrane 3671 is laid over upperhousing component 3601U. In one embodiment, membrane 3671 includes ananti-microbial layer. Membrane 3671 may also include electrical contactsthat serve as buttons.

An LCD assembly 3681 is provided on a PCB 3683. LCD assembly 3681includes an LCD frame 3673. Deformable frame tabs 3677 are provided onLCD frame 3673 to engage with the underside of PCB 3683. As such, LCDframe 3673 is grounded to PCB 3683. LCD assembly 3681 further includesan LCD screen (and associated circuitry) 3678 and backlight 3679. LCDassembly 3681 is mounted to upper housing component 3601U, as shown inFIGS. 36B and 36C.

Mounted on bottom housing component 3601B is a barcoding systemincluding scanner 3685 and lens 3691. Scanner 3685 is coupled to bottomhousing component 3601B with mounting plate 3687 and screws 3688. Thebarcoding system may include a 2D or 3D scanner, and may be used toidentify a patient, test strip, and/or healthcare provider.

On the underside of LCD assembly 3681 in a communications moduleincluding a WiFi module 3661 mounted on a WiFi PCB 3663. WiFi PCB 3663is then coupled to carriage 3669, which is then attached to LCD assembly3681. Wires 3667 connect WiFi module 3661 to antennae 3666, which sit onthe side of upper housing component 3601U. A shield 3668 is thenattached to the underside of LCD assembly 3681.

FIG. 36D illustrates the final assembly steps for the analytemeasurement device. A replaceable strip port module 3600 is insertedwithin a receptacle formed by cut-outs in both the upper and bottomhousing components 3601U, 3601B. A mounting screw 3688M is used tosecure the module 3600 to the housing. Additional system componentsinclude an ergonomic pad 3657, a label 3656, plugs 3658, and cover 3659.Additionally, a battery compartment 3655 is provided with a batterycontact 3692 and a battery cover 3655C.

The embodiments presented herein provide further advantages such as: theability to upgrade strip port modules as new test strip technologiesevolve; the ability to clean or sterilize a strip port module; and theability to allow users to replace strip port modules without returningthe entire measurement system to the manufacture.

Certain embodiments relate to in vivo (e.g., continuous monitoring)systems. A continuous monitoring system typically includes a sensor thatis worn or placed below the skin, a transmitter that collects glucoseinformation from the sensor, and a receiver that collects theinformation from the transmitter. The sensor can collect glucose levelinformation continuously, periodically, or at other intervals.Advantageously, a user is relieved from having to repeatedly lance hisor her body to collect a blood sample once the sensor is inserted,although the sensor (e.g., an electrochemical sensor that is insertedinto a body) can be replaced. U.S. Pat. No. 6,175,752, which is herebyincorporated by reference in its entirety, discloses additional examplesof a continuous monitoring system.

Embodiments of the present disclosure relate to components of acontinuous monitoring system that may be replaceable. In one embodiment,the interface between the sensor and the transmitter may becomecontaminated. The transmitter or sensor control unit, for example, mayhave an interface with the sensor that has been molded to form a barrierbetween the transmitter's contacts and circuitry internal to thetransmitter. This allows the transmitter's contacts to be washed withoutdamaging the transmitter's circuitry. Alternatively, the contacts may beincluded in a replaceable port that can be replaced as needed.Similarly, the interface on the sensor may be molded to form a barrierto contamination or be replaceable.

In these examples, the strip connectors or ports can be used withcontinuous monitoring systems. As discussed herein, the sensor controlunit or transmitter typically has a port to interface with the sensor.This port can be molded such that the contacts can be cleaned to prolongthe MTBF. Alternatively, the port can be replaceable and/or washable. Areplaceable port allows the continuous system to adapt to differentsensor form factors.

Embodiments of the present disclosure further extend to kits. Examplesof a kit include a measurement device with one or more strip connectors.In some kits, different strip connectors or ports for different types ofstrips may be included. This allows the measurement device to be usedwith different strip form factors. The kits may also include a pluralityof test strips. In certain examples, the measurement device may beconfigured for use with disposable test strips as well as with teststrips that are configured for continuous monitoring systems. Thus, themeasurement device may include a receiver to receive information from atransmitter that collects glucose information from an inserted sensor.The measurement device may also include a strip connector, such as thosedisclosed herein, for use with single use test strips.

Barriers and Seals for Strip Ports and Analyte Measurement Devices

In some aspects of the present disclosure, a barrier device is providedthat couples to a strip port of an analyte measurement device and servesto prevent liquids from traveling down the test strip and entering thestrip port. In one embodiment, the barrier device removably couples to astrip port that is fixedly integrated within the analyte measurementdevice. In such case, the barrier device is shaped and sized to fitwithin the strip port and be maintained in the strip port until removed.The barrier device may include, for example, retention elements thatcooperate with other retention elements on the strip port or measurementdevice to secure the barrier device in the strip port. Any variety ofretention elements may be used, such as fasteners, latches, rivets,hoops, screws, tabs, etc., for example. The retention elements on thebarrier device may also be configured to cooperate with existingelements in the strip port or on the analyte measurement device. Forexample, the barrier device may include retention elements that areshaped and sized to engage in an LED slot or other existing element inthe strip port, or receptacle of the meter including the strip port.

In another embodiment, the barrier device may be integrated with areplaceable strip port module that removably couples to an analytemeasurement device. The barrier device may be fixedly attached to thereplaceable strip port module and remain as a single integrated andinseparable component of the strip port module. Alternatively thebarrier device may be removably coupled to the replaceable strip portmodule such that it can be separated from the replaceable strip portmodule for cleaning or for replacement purposes, for example. Aninserted test strip electrically couples the strip port module which iselectrically coupled to the measurement device.

It should be appreciated that the barrier is not required to provide acompletely liquid tight seal. In some instances, the barrier may serveto minimize any gap or opening so that surface tension would preventadditional penetration of liquid into the barrier and strip port.

In one embodiment, the barrier is reusable and sufficiently durable tobe cleaned and disinfected or sterilized after each use for a multiplenumber of uses. In other embodiments, the barrier is for single use anddisposable, and thus selecting an inexpensive material and componentsfor the device may be desirable from a cost standpoint.

The barrier may be made from a variety of materials, for example, apolymeric material such as plastic, and/or an elastomeric material. Apolymeric material may include a coating, such as an absorbent materialand/or an elastomeric material. In some instances, the material shouldenable the barrier to be cleaned and disinfected with cleaning materialsor solvents. In one embodiment, the barrier is made from an elastomericmaterial such as silicone, which is compatible with cleaning anddisinfection for re-use. It should be appreciated that the barrier mayvary in elasticity such as to provide varying degrees of rigidity whilestill remaining elastic.

In one embodiment, the barrier includes one or more protrusions, such asflaps, that are disposed near the strip port opening of the strip portconnector. The flaps extend from the strip port and are configured toprovide sufficient coverage of the strip port opening to protect themeter from contamination. For example, the strip port may include afront flange around the strip port opening of the strip port and havethe one or more flaps extending from the front flange towards the stripport opening.

The flaps are configured to minimize test strips from getting “snagged”on the flaps when inserted into the strip port, which could bend orotherwise damage the contacts on the test strips upon insertion, forexample. The flaps are also configured to not block the strip portopening. In some instances, the flaps are oriented to guide the teststrip to the strip port opening of the strip port.

In one embodiment, the flaps are angled inward such that the end of theflaps near the strip port opening are further inside the strip port thanthe other end of the flaps connected to the front flange. In this way,the test strip may easily be inserted within the strip port openingwhile contacting the flaps without becoming obstructed by the flaps. Itshould be appreciated that in other embodiments, the flaps may be angledoutward such that the end of the flaps connected to the front flange arefurther inside the strip port than the other end of the flaps near thestrip port opening; or alternatively, not angled and extending straightdown such that the end of the flaps connected to the front flange areapproximately the same distance within the strip port than the other endof the flaps near the strip port opening.

In one embodiment, four flaps are included—a top flap, bottom flap, andtwo side flap, wherein the top flap, for example, coincides with theside of the test strip that receives the fluid sample. In anotherembodiment, two flaps are included—a top flap and a bottom flap, whereinthe top flap, for example, coincides with the side of the test stripthat receives the fluid sample. In yet another embodiment, a single flapprovided, wherein the single flap coincides with the side of the teststrip that receives the fluid sample. It should be appreciated that inother embodiments, other number of flaps may be included and oriented.

FIG. 37A illustrates a barrier, according to one embodiment. In theembodiment shown, a barrier device that is shaped and sized to removablyand operably couple to a strip port of an analyte measurement device,such as a glucose meter for example. Meter 3801 includes a strip port3802 that is configured to receive and operate with barrier device 3803.Barrier device 3803 includes a front flange 3804 around an aperture orslit 3815 that aligns with the strip port opening 3808 of the strip port3802 when the barrier device 3803 is coupled to the strip port 3802. Inthis way, a test strip 3806 may be inserted within the aperture 3815 andthrough the strip port opening 3808 of the device 3801.

Barrier device 3803 is shown comprising sealing flaps 3805 a,b extendingfrom front flange 3804 inward toward the aperture 3815 (and strip portopening 3808 when coupled). The flaps 3805 a,b are generally square orrectangular shaped, and may be trapezoidal shaped (e.g., with theshorter parallel side closest to the aperture 3815). It should beappreciated that in other embodiments, other varying shapes and sizesmay be used.

The inwardly extending flaps are shown in FIG. 37B, which illustrates aside view of the barrier device and strip port shown in FIG. 37A. Thebarrier device 3803 includes flaps 3805 a,b which extend inwardly towardthe aperture 3815 (and strip port opening 3808 when coupled). The flaps3805 a,b are oriented such that the center point between the ends isapproximately aligned with the strip port opening 3808 when coupled.

The sealing flaps 3805 a,b comprise a top flap 3805 a and a bottom flap3805 b. The sealing flaps 3805 a,b extend a sufficient distance toprovide an approximate distance between the two flaps to receive a teststrip 3806 and to slightly contact the test strip 3806. The distance mayvary, and the more elastic the flaps 3805 a,b are, the closer the twoflaps may be to allow the test strip 3806 to push through the flaps 3805a,b. In one embodiment, the ends of flaps 3805 a,b contact one another.In other embodiments, flaps 3805 a,b do not necessarily contact the teststrip 3806 but are sufficiently close to prevent contamination.

The flaps 3805 a,b include a width that is approximately the width ofthe sidewalls 3809 of the strip port module 3803 to enable a barrier onthe sides of the test strip. In other embodiments, the barrier maycomprise side flaps, such as shown in FIG. 37C, which illustrates afront view of a strip port having four barriers, according to oneembodiment. The side flaps 3805 c,d are shown also angling inwardlytowards the aperture 3815 (and strip port opening 3808 when coupled),and extending to the sides of the side flaps 3805 a,b to preventcontamination from entering the strip port 3802 on the sides of the teststrip 3806 when inserted within the strip port opening 3808.

The barrier may be disinfected or is disposable after use. For example,the barrier may be removed by a user and thereafter disinfected orthrown away. In some instances, the barrier may be disinfected orotherwise cleaned while still coupled to the measurement device. Thebarrier device includes a releasing element 3807 that enables thebarrier device 3803 to be removed from the strip port 3802 of the device3801. For example, the releasing element may be a finger tab that allowsa user to grip with two fingers and pull, or otherwise disengage, thebarrier device out of the strip port.

In some aspects of the present disclosure, a replaceable strip portmodule is provided. The replaceable strip port module may be internallysealed to contain fluid or other contaminants within the strip portmodule. For example, the strip port module may include a seal, gasket,or other seal-providing element around the strip port opening, forinstance, to provide a seal with an inserted test strip. In oneembodiment, the replaceable strip port module may be removed and cleanedand/or soaked in cleaning solution, and re-used thereafter.

FIG. 38 illustrates a replaceable strip port module, according to oneembodiment. Replaceable strip port module 3903 removably andelectrically couples to the strip port receptacle 3902 of analytemeasurement device 3901. As shown, the opening 3908 of the strip portreceptacle 3902 is not sealed and may enable fluid or other contaminantsfrom entering the strip port when the replaceable strip port module 3903is not coupled.

The strip port module 3903 may snap in the device 3901, or otherwisesecurely engage the strip port receptacle 3902. For example, thereplaceable strip port module 3903 of the embodiment shown also includesconnector 3920 that mates with the opening or socket 3908 of the stripport receptacle 3902 of analyte measurement device 3901. Additionalretention elements, such as described above, may also be used to furthersecure the replaceable strip port module 3903 within the strip portreceptacle 3902. The module 3903 may “snap” into the device 3900 andmake electrical connection.

The contacts 3920 may take the form of conductive pads, which arecontacted by contact fingers disposed on the measurement device 3900 to“wipe” the contacts 3920 as the connector 3920 is passed by the fingersinto the receptacle 3902.

As the strip port module 3903 is sealed internally, any fluid within thestrip port module cannot travel to the strip port receptacle 3902 andcontaminate the meter electronics. Furthermore, when coupled, thereplaceable strip port module 3903 serves as a barrier that sufficientlyseals the strip port receptacle 3902 from fluid or other contaminants.In the embodiment shown, the strip port connector 3920 includes asubstrate with contacts 3921 that enable electrical coupling with thestrip port 3902 of the device 3901 to provide for an electricalconnection between the strip port 3902 and the test strip.

As stated above, the interior of the strip port module 3903 is sealed tocontain liquids within the module 3903. Furthermore, the strip portmodule 3903 shown includes flanges that provide additional surface areaaround the opening for the test strip to keep the strip port module andmeter free from contamination.

In the embodiment shown, the replaceable strip port module 3903 includesa front flange 3904 having surfaces 3905 a,b which surround an apertureor strip port opening 3915 for a test strip to be inserted through. Inanother embodiment, the surfaces 3905 a,b are flaps, such as thosedescribed in FIGS. 37A-C.

Furthermore, replaceable strip port module 3903 may be removed by a userand thereafter disinfected or thrown away. For example, the replaceablestrip port module 3903 may be soaked in a cleaning solution ordisinfectant solution and then dried thereafter before being recoupledto the measurement device for re-use. Any plastic, metal contacts, andelectrical connection pad materials may be selected to be compatiblewith cleaning and disinfecting solutions. In some instances, thereplaceable strip port module 3903 may be disinfected or otherwisecleaned while still coupled to the measurement device. The externalsurfaces of the strip port and measurement device may be wiped down tokeep the remainder of the analyte measurement device clean.

The replaceable strip port module 3903 is shown including a releasingelement 3907 that enables the replaceable strip port module 3903 to beremoved from the strip port receptacle 3902 of the device 3901. Forexample, the releasing element may be a finger tab that allows a user togrip with two fingers and pull, or otherwise disengage, the replaceablestrip port module 3903 device out of the strip port receptacle 3902.

It should be appreciated that the replaceable strip port module may bereplaced with another replaceable strip port module after multiple uses,or after the replaceable strip port module is too contaminated forcleaning, or to be used while the strip port module is being cleaned ordisinfected.

In multi-patient use, the replaceable strip port module may be cycled sothat the disinfected strip ports are used once per patient and thenremoved for cleaning and disinfection again, for example. To control thenumber of use/cleaning cycles, complete batches of replaceable stripport modules may be replaced at selected intervals (e.g., 3 months, 6months, or 12 months, depending on the frequency of re-use) for example.This may also apply to single patient use, allowing the user to cleanand disinfect the replaceable strip port module when desired and thenre-install the strip port module in the meter.

In some aspects of the present disclosure, an analyte measurement deviceincludes a strip port that is internally sealed and also sealed withrespect to the meter, such as with a gasket between the strip port andhousing. In this way, a sufficiently liquid tight seal is provided thatpermits the strip port to be soaked or flushed in place on themeasurement device, even though other parts of the measurement devicemay not be sealed. It should be appreciated that while the rest of themeter is not required to be sealed, in embodiments providing as muchsealing and protection as possible in the measuring device minimizes thechance of accidentally damaging the meter while cleaning.

For example, the strip port can be soaked with a cleaning ordisinfecting solution (e.g., from an eyedropper or other applicationdevice) and left to soak for some time to thoroughly clean the stripport before being shaken and/or poured out and let dry. As the stripport is internally sealed, the strip port electronics are protected fromcontamination. The measurement device may then be wiped to eliminate anystray fluid. In some instances, maintaining the measuring device at acertain position or angle may minimize the risk of liquid intrusion intothe meter. Instructions advising the user of such position or angle maybe provided to the user, for example. In one embodiment, the strip portis angled within the housing of the measuring device in a position tofacilitate drainage of cleaning solution.

FIG. 39 illustrates an analyte measurement device 4000 including a stripport 4001 that is internally sealed and sealed with respect to the restof the device, according to one embodiment. Because strip port 4001 isinternally sealed, liquid entering the strip port 4001 is prevented fromentering further into the device 4000 via the strip port 4001. Eyedropper 4004 includes disinfecting solution 4003 and is used to applydisinfecting solution 4003 within the strip port 4001 of device 4000 toclean the strip port 4000 of contaminants. The strip port 4001 may thenbe soaked, for example, and later drained. Since the strip port 4001 issealed with respect to the housing of the device 4000, fluid cannotenter device around the strip port 4001 and contaminate the meterelectronics.

It should be appreciated that in such case the remainder of themeasurement device should be carefully designed to prevent liquid fromentering unsealed portions of the meter, such as control buttons orbattery compartment for example. FIG. 40 illustrates fluid flowing offan analyte measurement device, according to one embodiment. Meter 4001includes one side 4005 that does not contain any unsealed areas of thedevice (e.g., the bottom of the device that includes only the housing ofthe device), and another side 4006 that includes one or more unsealedportions of the device, such as buttons, connection ports, etc. To avoidintrusion of the disinfecting solution into the unsealed portions, thedevice 400 is oriented with the side 4005 facing up to allow any excessdisinfecting solution that does not enter the strip port 4001 to rolloff sealed portions of the device 4000, such as side 4005, as shown bydirectional arrows E.

In some aspects of the present disclosure, a sealed strip port isprovided that enables liquid cleaning or disinfecting solution to “flowthrough” the strip port. In one embodiment, the port is sealed toprevent intrusion into the housing, but allows solution to be flow orflush through the port and drain out an outlet of the measurementdevice. In this way, the strip port may be flushed out to provide a morethorough cleaning.

For example, FIGS. 41A-B illustrate a strip port that permits solutionto flow through the strip port, according to two embodiments. Analytemeasurement device 4200 includes a strip port 4201 that provides asealed path 4213 within and through the device 4200 to an outlet 4212disposed in the housing. In this way, solution 4203 from eye dropper4204 is applied within strip port 4201 and allowed to flow through thesealed path 4213 and out the outlet 4212 in the housing to avoidpossible external exposure of the contacts (mechanical, ESD, etc.), asrepresented by directional arrow F.

The remainder of the device 4200 remains sealed from the strip port andsealed path, to prevent intrusion of the solution into the rest of thedevice 4200. In FIG. 41A, the sealed path 4213 is generally straightthrough one end of the device to allow the fluid to flow through thedevice 4200 to the outlet 4212. In FIG. 41B, the sealed path 4213extends sideways for a more significant distance within the device—e.g.,along the longitudinal axis of the device 4200 and parallel to printedcircuit boards within the device 4200. In one embodiment, certaincontacts 4220 are exposed to the cleaning solution to clean thecontacts. It should be appreciated that the sealed path may be directedin one or more directions to provide the most advantageous path for aminimum chance of intrusion or otherwise improper contact withunprotected portions of the device.

In some instances, a stand or other fixture may be used to keep themeasurement device in the correct position or angle to minimize the riskof intrusion into a non-sealed portion of the measurement device.

In some aspects of the present disclosure, an analyte measurement deviceis provided that is entirely and sufficiently liquid tight sealed topermit the device to be fully or significantly submerged into a liquid,such as a cleaning or disinfecting solution. The measurement devicewould thus be disinfected by soaking, and the meter must be sufficientlyliquid tight sealed to prevent intrusion of liquid within inappropriateparts of the device when submerged in shallow solutions. It should beappreciated that the interfaces of the measuring device may be selectedor modified accordingly to provide such a liquid tight seal. Forexample, some interfaces, such as jog wheels or connector openings maybe limited to reduce the number of seals. For example, wirelessconnections may be used in place of wired connections to eliminateconnection ports. In some instances, connector opening may include asealing cover—e.g., a rubber cover that fits within the connectoropening to block the connector opening from fluid. Battery compartmentscovers may be sealed to prevent fluid from entering the batterycompartment. In some instances, rechargeable batteries may be used toeliminate having sealed battery compartment covers.

FIG. 42 illustrates a sealed analyte measurement device submerged influid (e.g., cleaning or disinfecting solution), according to oneembodiment. As shown, measurement device 4300 is fully submerged into ashallow volume of disinfecting solution 4303 contained in a container4310. Device 4300 includes strip port 4302, buttons 4304, display 4305,which are all disposed within housing 4303. Each of the components aresealed with respect to itself as well as with respect to the housing toprevent intrusion of fluid within the device 4300. Other components notshown may also be sealed if present, such as battery compartment cover,communication ports (e.g., USB or Bluetooth ports). Any sealing materialor elements may be used, such as elastomeric materials, rubber seals,gaskets, and/or sealing films and coatings, etc.

Analyte measurement devices may be used in hospitals or other healthcare facilities, and furthermore, used with multiple users and/or acrossmultiple departments in the facility. In some aspects of the presentdisclosure, a covered analyte measurement device is provided thatincludes a cover material or layer that seals or otherwise protects theanalyte measurement device from microbes or other contaminants. Thecovered analyte measurement device is thus microbially resistant in thesense that the cover material facilitates cleaning of the device toreduce cross contamination—e.g., from use with multiple users—from avariety of potentially dangerous bacteria such as Methicillin-ResistantStaphylococcus Aureus (MRSA).

In one embodiment, the cover material is one contiguous see through skinwhich covers the analyte measurement device and its susceptiblecomponents of the analyte measurement device—e.g., any buttons, batterycover, screen, case joints, etc. In another embodiment, the covermaterial does not cover the entire device, but only the susceptiblecomponents of the device.

The cover material provides an opening for the strip port to enable atest strip to be inserted into the strip port. The opening may be, forexample, a sleeve that minimizes access to only when a test strip isinserted. The cover material may be made from any variety of materialsthat enable the cover to be cleaned and that are semi-transparent orfully-transparent. For example, in one embodiment the cover material issilicone.

In one embodiment, the cover is made from a material, or includes acoating, that changes color when wet with alcohol, such as from analcohol swab or pad that is used to clean the cover material. In anotherembodiment, the cover is made from a material that becomes clear (e.g.,from semi-opaque or fully opaque for example) when wet through acleaning protocol (e.g., from a cleaning or disinfectant solution), andthus allowing or facilitating use. In yet another embodiment, a messageor icon indicating instructions to clean the device is provided ordisplayed—e.g., a “clean me” message displayed on the display of themeasurement device. The device may be programmed not to work, forexample, to require acknowledgement in such case, and further, may notpermit the device from being used without acknowledgement (e.g., thatthe device is cleaned).

Cleaning Tool

In some aspects of the present disclosure, a strip port cleaning tool isalso provided. The cleaning tool enables a user to gently rub thecontact surfaces of the strip port contacts and remove any solids thatmay have dried onto the contacts, for example. The strip port cleaningtool is shaped and sized to facilitate cleaning of the strip port (e.g.,replaceable strip port module or fixedly attached strip port) of ananalyte measurement device. For example, in one embodiment, the cleaningtool includes a handle and an end shaped like a test strip to insertinto the strip port. The material of the tool may vary, but shouldprovide a mild abrasive so that contact surfaces are cleaned but notdamaged. The thickness is important to ensure the strip port contactsare not damaged during use of the tool. Using the tool after soaking thestrip port to first soften any dried material may assist with thecleaning process. The strip shaped end of the tool may, in someinstances, be dipped in a solution prior to inserting into an internallysealed strip port. The solution may clean the tool and/or provide thetool with solution for cleaning the strip port. The tool may be die-cut,for example, from materials (e.g., paper, plastic, etc.) laminated tooprovide the appropriate cleaning, absorbent, abrasive surface andmechanical rigidity. In one embodiment, the tool may include two ends,on for wet cleaning and one for dry rubbing afterwards. The wet cleaningend may be semi-absorbent and semi-abrasive for example to retain somecleaning solution for application to the strip port. The dry cleaningend may be absorbent and less abrasive for example to facilitate dryrubbing.

FIG. 43 illustrates a cleaning tool for a strip port of analytemeasurement device, according to one embodiment. As shown, cleaning tool440 includes a handle 4401 that is shaped and sized to be held by auser. The shape may vary but should be conducive to being comfortablygripped by the user for manipulation and use of the tool. The tool 4400also includes a cleaning portion 4402 that extends from the handle andis shaped and sized similar to a test strip and such that it may fitwithin the strip port opening of the strip port. The cleaning portion4402 may thus be inserted into the strip port opening to clean thecontacts. In one embodiment, the width and thickness of the cleaningportion closely approximates the width and thickness of the test stripto facilitate cleaning of the contacts without damaging the strip port.The width and thickness may be slightly smaller than that of the teststrip to enable the cleaning portion to enable some movement for rubbingor cleaning.

Strip Port Interface

In some aspects of the present disclosure, a strip port interface isprovided that protects an analyte measurement device from fluid ingressinto the device. Fluid ingress is a function of both of the potentialenergy needed to enter the meter, as well as the potential energy oftaking alternative routes. By providing alternative paths, for example,fluid ingress can be minimized without being constrained to making thestrip and strip port opening as tight a fit as possible, which may leadto difficulty in inserting the test strip.

The strip port interface is configured to couple to the strip port of ananalyte measurement device. In one embodiment, the strip port interfaceis fixedly attached to the measurement device and integral to the stripport. In another embodiment, the strip port interface is removablycoupleable to the device.

A test strip is inserted through the strip port interface and thenthrough the strip port opening to electrically contact the strip portelectronics. The strip port interface wicks any fluid (e.g., travelingalong the test strip and toward the strip port opening) away from thestrip port opening of the strip port of the measurement device toprevent fluid from entering the strip port and contaminating strip portelectronics. The interface provides alternative paths and mayadditionally utilize capillary action to draw fluid away from the stripport opening along the alternative paths. In one embodiment, paths areprovided for displacing air to escape as fluid enters the strip portinterface. This reduces the pressure potential, for example, to assistwith guiding the fluid away from the strip port.

FIGS. 44A-C illustrate a strip port interface, according to oneembodiment. FIG. 44A illustrates a strip port interface coupled to ananalyte measurement device. FIG. 44B illustrates a perspective view ofthe strip port interface with a test strip inserted therein (shownwithout the analyte measurement device). FIG. 44C illustrates a crosssectional side view of the strip port interface and test strip shown inFIG. 44B, along plane P.

The strip port interface 4601 is fixedly attached to analyte measurementdevice 4600 and receives a test strip 4602. Strip port interface 4601includes paths 4603 and 4604 formed within the interface around theaperture 4609 of the interface in which the test strip is inserted. Thepaths 4603 are formed on the exterior surface of the strip portinterface 4601 near the aperture, and the paths 4604 are formed belowthe exterior surface of the fluid wicking interface 4601 near theaperture. The paths are aligned generally along the direction ofgravity. The paths may be formed as narrow paths sized for capillaryaction to wick away fluid from the strip port opening. For example,fluid 4605 traveling along the test strip 4602 towards the aperture 4609contacts paths 4603 and is wicked via capillary action along paths 4603away from the strip port opening of the device. Any fluid 4605 that isnot guided along path 4603 then encounters paths 4604 and is wicked viacapillary action, or otherwise guided along path 4604. The fluid may beguided, for example, external to the device (e.g., off to the side ofthe device), etc.

In one embodiment, some or all of the paths 4604 serve to displace airto escape as fluid enters the strip port interface. In this way, thepressure potential is reduced, for example, to assist with guiding thefluid away from the strip port. It should be appreciated that in someembodiments, the paths may serve both purposes of guiding fluid away, aswell as displacing air.

FIGS. 45A-C illustrate a strip port interface, according to oneembodiment. FIG. 45A illustrates a strip port interface coupled to ananalyte measurement device. FIG. 45B illustrates a perspective view ofthe strip port interface with a test strip inserted therein (shownwithout the analyte measurement device). FIG. 45C illustrates a crosssectional side view of the strip port interface and test strip shown inFIG. 45B, along plane P.

The strip port interface 4701 is fixedly attached to analyte measurementdevice 4700 and receives a test strip 4702. Strip port interface 4701includes path 4710 (e.g., narrow groove) formed within the interfacearound the aperture 4709 of the interface in which the test strip isinserted. The path 4710 extends along plane P from the aperture 4709outward to a reservoir 4711. Fluid 4705 traveling along the test strip4702 towards the aperture 4709 contacts the path 4710 and is guidedalong path 4710 into reservoir 4711. The fluid may accumulate withreservoir 4711 or be guided away from the strip port opening of thedevice. In some instances, the path or narrow groove is sized forcapillary action to wick the fluid away from the strip port opening.

FIGS. 46A-C illustrate a strip port interface, according to anotherembodiment. FIG. 46A illustrates a strip port interface coupled to ananalyte measurement device. FIG. 46B illustrates a perspective view ofthe strip port interface with a test strip inserted therein (shownwithout the analyte measurement device). FIG. 46C illustrates a crosssectional side view of the strip port interface and test strip shown inFIG. 46B, along plane P.

The strip port interface 4801 is fixedly attached to analyte measurementdevice 4800 and receives a test strip 4802. Strip port interface 4801includes an absorbent insert 4820 that is disposed within the interfaceat or near the aperture of the interface in which the test strip isinserted. The absorbent insert 4820 is positioned to come in contactwith, or be very close to, the test strip 4802 such that any fluid 4805traveling along the test strip contacts the insert 4820 and is absorbedand prevented from continuing within the strip port. The absorbentinsert 4820 may include a hole or slit within the insert 4820 that formsan aperture for the test strip 4805 to pass through. The absorbentinsert 4820 may be made from any variety of absorbent materials. Theamount of absorbent material may vary but should sufficient enough toabsorb at least an approximate sample amount. While the absorbentmaterial is circular in the embodiment shown, it should be appreciatedthat other shapes and sizes may be implemented in other embodiments.

In one embodiment the interface is integrated within the strip port andnon-removable. The strip port may be integrated within the analytemeasurement device or be a replaceable strip port module that may beremovably coupled to the measurement device. For example, in oneembodiment the strip port interface is integrated within a cap of areplaceable strip port module, such as one described in previoussections.

The strip port interface may be made from any variety of materials. Inone embodiment, the interface is a wipeable material such as a polymericmaterial (e.g., plastic), one or more metals or metal-alloys, glass,etc. In another embodiment, the interface may be made from an absorbentmaterial, which may be disposed of after use, for example. The stripport interface may be made from materials that are hydrophilic or thatinclude a hydrophilic coating. In one embodiment, the strip portinterface is made from a material that changes color when wet toindicate that device is contaminated.

Absorptive Elements

While fluid samples, such as blood, is needed to interact with thechemistry of a test strip, excess fluid should not enter the measurementdevice and contaminate the device. In some aspects of the presentdisclosure, one or more absorptive elements are provided that areconfigured to couple to the entrance of a strip port in order to preventliquids or other contaminants from entering the strip port and damagingelectronics therein.

In some instances, the one or more absorptive elements are included onan absorptive guard coupled to the strip port such that the absorptiveelements are positioned to contact the test strip to absorb any excessfluid approaching the strip port opening. The absorptive element may bemade of any material that absorbs fluid. When one absorptive element isused, the absorptive element is positioned to coincide with the side ofthe test strip that the fluid sample is applied. In one embodiment,absorptive guard comprises two absorptive elements that are positionedsuch that the test strip enters between the two absorptive elements inorder to enter the strip port opening. In this way, the two absorptiveelements are disposed on opposite sides of the major surfaces of thetest strip to ensure that any fluid flowing down the body of the teststrip is absorbed by an absorptive element. Having absorptive elementson both of the major surface sides of the test strip ensures that anabsorptive element is positioned on the fluid receiving side of the teststrip, regardless of which way the test strip is inserted into the stripport. Furthermore, if any excess fluid is accidently applied to theopposite side than the fluid receiving side and then flows down the teststrip, the other absorptive element will absorb the fluid and preventthe strip port electronics from being contaminated.

In one embodiment, the absorptive elements may be removable from theabsorptive guard to enable the absorptive elements to be cleaned and/orreplaced with new absorptive elements. In such case, the absorptiveguard includes a frame and securing element that secures the absorptiveelement to the frame when coupled. The absorptive guard includesretaining elements that are used to couple and maintain the absorptiveguard to the strip port. The strip port may be integrally formed withinan analyte monitoring device or may be a replaceable strip port modulethat removably couples to the device.

In another embodiment, the absorptive elements are fixedly attached tothe absorptive guard and the absorptive guard is removably coupled tothe strip port when the absorptive guard is cleaned and/or replaced witha new absorptive guard.

FIGS. 47A-D illustrates a test strip at various points when beinginserted into a strip port having an absorptive guard coupled thereto,according to one embodiment. Strip port 4501 includes strip portelectronics 4505 disposed inside, and an absorptive guard coupled to theentry of the strip port 4501. In the embodiment shown, the absorptiveguard is fixedly attached to the strip port, but may be removablycoupled to the strip port in other embodiments. Absorptive elements 4503are removably coupled to the absorptive guard 4502—e.g., via securingelements (not shown) such as fasteners, latches, rivets, hoops, screws,tabs, etc. The absorptive elements 4503 are positioned on the absorptiveguard 4502 and aligned with the strip port opening 4515 such that a teststrip 4505 must be inserted between the absorptive elements 4503 toenter the strip port 4501. As shown in FIG. 47A, the absorptive elements4503 are positioned to receive the test strip 4504. The test strip isinserted in between the absorptive elements 4503 and through the stripport opening 4515 of the strip port 4501 to electrically couple to thestrip port electronics 4505, as shown in FIG. 47B. If fluid 4506, suchas excess sample fluid, flows along the test strip 4504 towards thestrip port 4501, the fluid 4506 contacts the absorptive elements 4503and prevented from entering the strip port and contaminating the stripport electronics, as shown in FIG. 47C. The test strip 4504 may then beremoved after the measurement is performed by the analyte measurementdevice. The absorptive elements 4503 may then be removed from theabsorptive guard, as shown in FIG. 47D, to be cleaned and/or disposed ofsuch that new absorptive elements may be coupled for use.

It should be appreciated that the entire absorptive guard may bereplaced in other embodiments, such that the entire absorptive guard maybe cleaned or disposed of. It should also be appreciated that in otherembodiments, the absorptive elements may be coupled directly to thestrip port, without an absorptive guard including a frame in which theabsorptive elements couple.

Orientation Detection

A common failure for some analyte measurement devices is the applicationof control solution such that the solution is gravity fed into the stripport connector. Such intrusion into the strip port may make the deviceinoperable or otherwise damage the device. In some aspects of thepresent disclosure, an analyte measurement device is provided thatincludes an gravity sensor or accelerometer that monitors or otherwisedetects the orientation of the device and indicates to the user when thedevice is in an incorrect orientation for performing a control solutiontest. In one embodiment, the gravity sensor or accelerometer isintegrated within the device, such as coupled to the printed circuitboard of the device and housed within the housing of the device. In someinstances, the gravity sensor or accelerometer is always active. Inother instances, the gravity sensor or accelerometer becomes activatedwhen a control solution test is initiated.

Methods related thereto are also provided. The methods includeinitiation of a control solution test; monitoring or otherwise detectingthe orientation of the device by a gravity sensor or accelerometer; andindicating to the user if the orientation of the device is improper forperforming the control solution test. The indication may be audibleand/or visual, such as an LED or message on a display for instance.Furthermore, the monitoring and detecting of the orientation may beconstantly active or activated upon initiation of a control solutiontest.

In some embodiments, the methods include providing instructions to theuser as to the correct orientation or how to achieve the correctorientation of the device for the control solution test. Theinstructions may include an image (e.g., a picture of the device in thecorrect orientation) or a video demonstrating the correct orientation.

In some embodiments, the methods include disabling the device orotherwise not permitting the user from completing a control solutiontest until the device is oriented properly to prevent damage to thedevice.

FIGS. 48A-B illustrate an analyte measurement device including a gravitysensor or accelerometer, according to one embodiment. Analytemeasurement device 4900 is shown including a strip port 4902 and gravitysensor or accelerometer 4906 disposed within the device 4900. Thegravity sensor or accelerometer 4906 is electrically coupled to theelectronics of the analyte measurement device and in communication withother electrical components of the device 2900, such as a microprocessor(not shown).

In FIG. 48A, measurement device 4900 is oriented improperly forperforming a control test solution. As shown, the strip port 4902 isoriented upward and thus gravity will draw excess or misdirectedsolution 4911 down into the strip port 4902. Device 4900 indicates thatthe device 4900 is in an improper position via a message on the display4910. The device may also provide an audible warning to further ensurethe user is warned. In one embodiment, the device does not enable theuser to perform a control solution test when the device is improperlypositioned.

In FIG. 48B, the user reorients the device 4900 to a proper orientationto perform a control solution test (e.g., a blood glucose measurement).The proper orientation may vary, but should avoid orientations where thestrip port 4902 is positioned such that gravity draws solution 4911toward the strip port 4902. Proper orientation may include for example,the device 4900 oriented such that gravity draws the solution 4911 awayfrom the strip port 4902 or otherwise does not draw solution 4911towards the strip port 4902. With the device in a proper orientation forperforming a control solution test, the device 4900 indicates that thedevice is in a proper orientation for the test, via a message displayedon the display 4910, for example. Again, the device may also provide anaudible indication that the device is properly positioned. In theembodiment where the device does not enable the user to perform acontrol solution test when the device is improperly positioned, thedevice 4900 would now enable the user to perform the test since thedevice is properly oriented.

Analyte Test Strips

Analyte test strips for use with the present devices can be of any kind,size, or shape known to those skilled in the art; for example,FREESTYLE® and FREESTYLE LITE™ test strips, as well as PRECISION™ teststrips sold by ABBOTT DIABETES CARE Inc. In addition to the embodimentsspecifically disclosed herein, the devices of the present disclosure canbe configured to work with a wide variety of analyte test strips, e.g.,those disclosed in U.S. patent application Ser. No. 11/461,725, filedAug. 1, 2006; U.S. Patent Application Publication No. 2007/0095661; U.S.Patent Application Publication No. 2006/0091006; U.S. Patent ApplicationPublication No. 2006/0025662; U.S. Patent Application Publication No.2008/0267823; U.S. Patent Application Publication No. 2007/0108048; U.S.Patent Application Publication No. 2008/0102441; U.S. Patent ApplicationPublication No. 2008/0066305; U.S. Patent Application Publication No.2007/0199818; U.S. Patent Application Publication No. 2008/0148873; U.S.Patent Application Publication No. 2007/0068807; U.S. patent applicationSer. No. 12/102,374, filed Apr. 14, 2008, and U.S. Patent ApplicationPublication No. 2009/0095625; U.S. Pat. No. 6,616,819; U.S. Pat. No.6,143,164; U.S. Pat. No. 6,592,745; U.S. Pat. No. 6,071,391 and U.S.Pat. No. 6,893,545; the disclosures of each of which are incorporated byreference herein in their entirety.

Integrated With Lancing Device

In another embodiment, an analyte measurement system may include anintegrated analyte test meter and lancing device for providing a bodilyfluid sample, such as a blood sample, and measuring an analyteconcentration, such as a blood glucose concentration. Examples of suchintegrated devices include systems and devices described in US PublishedApplication Nos. US2007/0149897 and US2008/0167578, the disclosures ofeach of which are incorporated herein by reference in their entirety.

Calculation of Medication Dosage

In one embodiment, the analyte measurement system may be configured tomeasure the blood glucose concentration of a patient and includeinstructions for a long-acting insulin dosage calculation function.Periodic injection or administration of long-acting insulin may be usedto maintain a baseline blood glucose concentration in a patient withType-1 or Type-2 diabetes. In one aspect, the long-acting medicationdosage calculation function may include an algorithm or routine based onthe current blood glucose concentration of a diabetic patient, tocompare the current measured blood glucose concentration value to apredetermined threshold or an individually tailored threshold asdetermined by a doctor or other treating professional to determine theappropriate dosage level for maintaining the baseline glucose level. Inone embodiment, the long-acting insulin dosage calculation function maybe based upon LANTUS® insulin, available from Sanofi-Aventis, also knownas insulin glargine. LANTUS® is a long-acting insulin that has up to a24 hour duration of action. Further information on LANTUS® insulin isavailable at the website located by placing “www” immediately in frontof “.lantus.com”. Other types of long-acting insulin include Levemir®insulin available from NovoNordisk (further information is available atthe website located by placing “www” immediately in front of“.levemir-us.com”. Examples of such embodiments are described in in USPublished Patent Application No. US2010/01981142, the disclosure ofwhich is incorporated herein by reference in its entirety.

Docking Station

In another embodiment, the analyte measurement system may include acorresponding docking station or one or more other peripheral devices.The docking station may include, among others, a transmitter wherebywhen the analyte measurement system is docked to the docking station,the analyte measurement system and docking station may communicate overa data network with, for example, a healthcare provider, for thetransfer of data or receipt of instructions or new dosage regimens. Thedocking station transmitter may be configured for transmission protocolsincluding, but not limited to, cellular telephone transmission, such ascode division multiple access (CDMA) or Global System for Mobilecommunications (GSM), internet communication, facsimile communications,and/or telephone communication. In another aspect, the docking stationmay also be configured to provide power for recharging a rechargeablebattery of the analyte measurement system. In another aspect, thedocking station may be configured for communication with a personalcomputer for additional storage, programming, and/or communication.

In another embodiment, a docking station such as described in U.S. Pat.No. 7,077,328 may be employed. As stated above, U.S. Pat. No. 7,077,328is incorporated herein by reference in its entirety.

In some aspects of the present disclosure, a docking station is providedthat serves as an information server for “docking” an analytemeasurement device such, as a glucose meter, and that also providesstorage and recharging capabilities for spare batteries, such asstandard batteries that can be recharged. For example, the dockingstation may serve as a docking station for an analyte measurementdevices described in the present disclosure.

Recharging batteries, such as two AA batteries, may take at least twohours to recharge, for example. If the docking station only rechargesinstalled batteries, then the user is faced with either docking themeter and absorbing the time cost of two hours, or buying and storing aseparate recharger. However, having a docking station that serves as aninformation server and that also provides storage and rechargingcapabilities for spare batteries, enables a user to switch in chargedbatteries from the docking station, and then place the exhaustedbatteries in the stations for recharging.

In one embodiment, the docking module and the battery charging moduleremain distinct such that existing related technologies may be appliedto save development time with integration. In another embodiment, thedocking module and the battery charging module are not entirelydistinct.

FIGS. 49A-B illustrate a docking station, according to one embodiment.Docking station 3700 includes a housing 3700 having a docking port 3702and battery compartment 3703. Docking port 3702 is shaped to form fitwith a compatible measurement device. In some instances, the dockingport 3702 may be form fitted to be compatible with multiple types ormodels of measurement devices. The docking port 3701 includes contacts(not shown) that mate with corresponding contacts on the measurementdevice to electrically couple the docking station and the measurementdevice. In this way, the docking station may recharge the installedbatteries in the measurement device when the device is docked in thedocking station.

Battery compartment 3703 is disposed within housing 3701 and configuredto hold one or more batteries separate from the measurement device 3705.For example, the battery compartment 3703 may be configured to hold thebatteries 3704 that are required to operate the meter. In otherembodiments, the battery compartment 3703 is configured to hold morebatteries, such as two sets of backup batteries, or different batteriesfor varying models or types of measurement devices. Contacts 3706 aredisposed within battery compartment 3703 and electrically couple thebatteries 3704 to the docking station to enable the batteries 3704 to becharged by the docking station. The docking station 3700 includes a ACpower cord, for example, to connect to an AC power source and charge theinstalled and separate batteries. In other embodiments, the dockingstation may connect to another device and receive power from theconnected device, or alternatively, include its own internal powersource.

In one embodiment, the docking station includes a removable chargingmodule that is removably coupled to the docking station. The removablecharging module may be, for example, structurally and/or electricallyseparable from the docking station. For example, FIG. 49C illustrates aremovable charging module, according to one embodiment. In theembodiment shown, removable charging module 3708 includes a batterycompartment frame 3707 having contacts 3706 that electrically couplewith the batteries 3704 when inserted within the battery compartmentframe 3707 of docking station 3700. Battery compartment frame 3707 isinserted within a corresponding receptacle 3711 of docking station 3700,for example. The receptacle includes contacts 3710 that electricallymate with contacts 3709 on battery component frame 3707. Contacts 3709are also electrically coupled to contacts 3706, which enable the dockingstation 3700 to electrically couple to batteries within the batterycompartment frame 3707 and recharge them.

It should be appreciated that in some embodiments more than oneremovable charging module may be disposed within the docking station.Further, in some instances, the docking station may be configured toreceive and operate with more than one type of removable rechargingmodule, such as removable charging modules from different measurementdevices and/or different redesigns and/or models. In some instances, theremovable charging module may be off-the-shelf and/or derived fromoff-the shelf recharging stations.

Strip Port Configured to Receive Test Strips for Different Analytes

In another embodiment, there is provided an analyte measurement systemfor multichemistry testing. The test strips are for chemical analysis ofa sample, and are adapted for use in combination with a measuring devicehaving a test port and capable of performing a multiplicity of testingfunctionalities. Each type of test strip corresponds to at least one ofthe testing functionalities, and at least some types of test strips haveindicators of the testing functionality on them. The test port isadapted for use in combination with a multiplicity of different types oftest strips and includes a sensor capable of specifically interactingwith the indicator(s) on the test strips, thereby selecting at least oneof the multiplicity of testing functionalities corresponding to the typeof test strip. Such system would include a strip port that can be usedto read a test strip for glucose and a test strip for ketone bodies.Examples of such embodiment are provided in U.S. Pat. No. 6,773,671,which is incorporated herein by reference in its entirety.

Strip Port Configured to Receive Test Strips Having Different Dimensionsand/or Electrode Configurations

In some embodiments, an analyte measurement system as described hereinincludes a strip port configured to receive test strips having differentdimensions and/or electrode configurations, e.g., as described in theU.S. patent application Ser. No. 12/695,947 filed on Jan. 28, 2010, andentitled “Universal Test Strip Port”, the disclosure of which isincorporated by reference herein in its entirety.

Test Strip Ejector

In some embodiments, an analyte measurement system as described hereinis configured to include an optional analyte test strip ejectorconfigured to eject an analyte test strip from a test strip port of theanalyte measurement system. An analyte test strip ejector may be useful,for example, where it is desirable to eject an analyte test stripcontaining a sample of bodily fluid, e.g., blood, following an analytemeasurement conducted using the analyte measurement system. This allowsa user of the analyte measurement system to dispose of the contaminatedanalyte test strip without touching the analyte test strip.

In some embodiments, the analyte test strip ejector slidably engages aportion of the housing of the analyte measurement system. The analytetest strip ejector may be configured such that upon insertion of ananalyte test strip into the test strip port, the analyte test stripejector is moved rearward with respect to the test strip port and in thedirection of insertion. In order to eject the analyte test strip, a userphysically moves the analyte test strip ejector forward with respect tothe test strip port and in the opposite of the direction of insertion.This movement in-turn exerts force upon the analyte test strip expellingit from the test strip port. Alternatively, the analyte test stripejector may be configured such that insertion of the analyte test stripinto a strip port of the analyte measurement system positions theanalyte test strip ejector in a “cocked” position, e.g., by engaging aspring mechanism. The analyte measurement system may include a button,switch, or other suitable mechanism for releasing the cocked ejectorfrom the cocked position such that it ejects the analyte test strip fromthe strip port of the analyte measurement system. Additional informationregarding analyte test strip ejectors is provided in the U.S. patentapplication Ser. No. 12/695,947, filed on Jan. 28, 2010, and entitled“Universal Test Strip Port.”

Splash-Proof Test Strip Port

In some embodiments, an analyte measurement system as described hereinis configured to include a contamination resistant test strip portand/or a splash-proof test strip port. In one such embodiment, the teststrip port includes one or more sealing members positioned so as tolimit and/or prevent internal contamination of the test strip port withfluids and/or particles present in the environment outside the teststrip port. In another embodiment, the test strip port includes aninternal beveled face which can limit and/or prevent ingress of one ormore external contaminants into the internal area of the test stripport.

Additional disclosure and examples of contamination resistant test stripports are provided in U.S. patent application Ser. No. 12/539,217, filedAug. 11, 2009, and entitled “Analyte Sensor Ports,” the disclosure ofwhich is incorporated by reference herein in its entirety.

In some embodiments, the test strip ports described herein can beconfigured to work with (e.g., engage with or operate in connectionwith) additional mechanisms and/or devices designed to limit and/orprevent contamination of the internal areas of the test strip portsthemselves or the internal areas of the analyte measurement system intowhich the test strip ports can be integrated. For example, mechanisms,devices and methods of protecting test strip port openings are describedin U.S. Patent Application Publication No. US2008/0234559, and U.S.Patent Application Publication No. US2008/0119709, the disclosure ofeach of which is incorporated by reference herein in their entirety.Test strip ports according to the present disclosure can also beconfigured to be replaceable and/or disposable, and/or configured so asto limit and/or prevent contamination of the analyte measurement systemin which the test strip port is integrated. Additional description isprovided, for example, in U.S. Application Publication No. 2010/0064800,the disclosure of which is incorporated by reference herein it itsentirety.

Implanted Analyte Sensor

In some embodiments, an analyte measurement system as described hereinmay include an implanted or partially implanted analyte sensor, e.g., asystem including an implanted or partially implanted glucose sensor(e.g., a continuous glucose sensor). A system including an implanted orpartially implanted glucose sensor may include an analyte measurementsystem as described herein, which is configured to receive analyte datafrom the implanted or partially implanted glucose sensor either directlyor through an intermediate device, e.g., an RF-powered measurementcircuit coupled to an implanted or partially implanted analyte sensor.In some embodiments, where an analyte measurement system according tothe present disclosure is integrated with an implanted sensor, theanalyte measurement system does not include a strip port for receivingan analyte test strip. In one embodiment, the analyte measurement systemmay be used to calibrate the analyte monitoring system, e.g., using onepoint calibration or other calibration protocol. For additionalinformation, see U.S. Pat. No. 6,175,752, the disclosure of which isincorporated by reference herein in its entirety. In some embodiments,the analyte measurement system may be configured to communicate with theimplanted or partially implanted analyte sensor via Radio FrequencyIdentification (RFID) and provide for intermittent or periodicinterrogation of the implanted analyte sensor.

Exemplary analyte monitoring systems that may be utilized in connectionwith the disclosed analyte measurement system include those described inU.S. Pat. No. 7,041,468; U.S. Pat. No. 5,356,786; U.S. Pat. No.6,175,752; U.S. Pat. No. 6,560,471; U.S. Pat. No. 5,262,035; U.S. Pat.No. 6,881,551; U.S. Pat. No. 6,121,009; U.S. Pat. No. 7,167,818; U.S.Pat. No. 6,270,455; U.S. Pat. No. 6,161,095; U.S. Pat. No. 5,918,603;U.S. Pat. No. 6,144,837; U.S. Pat. No. 5,601,435; U.S. Pat. No.5,822,715; U.S. Pat. No. 5,899,855; U.S. Pat. No. 6,071,391; U.S. Pat.No. 6,120,676; U.S. Pat. No. 6,143,164; U.S. Pat. No. 6,299,757; U.S.Pat. No. 6,338,790; U.S. Pat. No. 6,377,894; U.S. Pat. No. 6,600,997;U.S. Pat. No. 6,773,671; U.S. Pat. No. 6,514,460; U.S. Pat. No.6,592,745; U.S. Pat. No. 5,628,890; U.S. Pat. No. 5,820,551; U.S. Pat.No. 6,736,957; U.S. Pat. No. 4,545,382; U.S. Pat. No. 4,711,245; U.S.Pat. No. 5,509,410; U.S. Pat. No. 6,540,891; U.S. Pat. No. 6,730,200;U.S. Pat. No. 6,764,581; U.S. Pat. No. 6,299,757; U.S. Pat. No.6,461,496; U.S. Pat. No. 6,503,381; U.S. Pat. No. 6,591,125; U.S. Pat.No. 6,616,819; U.S. Pat. No. 6,618,934; U.S. Pat. No. 6,676,816; U.S.Pat. No. 6,749,740; U.S. Pat. No. 6,893,545; U.S. Pat. No. 6,942,518;U.S. Pat. No. 6,514,718; U.S. Pat. No. 5,264,014; U.S. Pat. No.5,262,305; U.S. Pat. No. 5,320,715; U.S. Pat. No. 5,593,852; U.S. Pat.No. 6,746,582; U.S. Pat. No. 6,284,478; U.S. Pat. No. 7,299,082; U.S.Patent Application No. 61/149,639, entitled “Compact On-BodyPhysiological Monitoring Device and Methods Thereof”, U.S. patentapplication Ser. No. 11/461,725, filed Aug. 1, 2006, entitled “AnalyteSensors and Methods”; U.S. patent application Ser. No. 12/495,709, filedJun. 30, 2009, entitled “Extruded Electrode Structures and Methods ofUsing Same”; U.S. Patent Application Publication No. US2004/0186365;U.S. Patent Application Publication No. 2007/0095661; U.S. PatentApplication Publication No. 2006/0091006; U.S. Patent ApplicationPublication No. 2006/0025662; U.S. Patent Application Publication No.2008/0267823; U.S. Patent Application Publication No. 2007/0108048; U.S.Patent Application Publication No. 2008/0102441; U.S. Patent ApplicationPublication No. 2008/0066305; U.S. Patent Application Publication No.2007/0199818; U.S. Patent Application Publication No. 2008/0148873; U.S.Patent Application Publication No. 2007/0068807; US patent ApplicationPublication No. 2010/0198034; and U.S. provisional application No.61/149,639 titled “Compact On-Body Physiological Monitoring Device andMethods Thereof”, the disclosures of each of which are incorporatedherein by reference in their entirety.

Integration with Medication Delivery Devices and/or Systems

In some embodiments, the analyte measurement systems disclosed hereinmay be included in and/or integrated with, a medication delivery deviceand/or system, e.g., an insulin pump module, such as an insulin pump orcontroller module thereof. In some embodiments the analyte measurementsystem is physically integrated into a medication delivery device. Inother embodiments, an analyte measurement system as described herein maybe configured to communicate with a medication delivery device oranother component of a medication delivery system. Additionalinformation regarding medication delivery devices and/or systems, suchas, for example, integrated systems, is provided in U.S. PatentApplication Publication No. US2006/0224141, published on Oct. 5, 2006,entitled “Method and System for Providing Integrated Medication Infusionand Analyte Monitoring System”, and U.S. Patent Application PublicationNo. US2004/0254434, published on Dec. 16, 2004, entitled “GlucoseMeasuring Module and Insulin Pump Combination,” the disclosure of eachof which is incorporated by reference herein in its entirety. Medicationdelivery devices which may be provided with analyte measurement systemas described herein include, e.g., a needle, syringe, pump, catheter,inhaler, transdermal patch, or combination thereof. In some embodiments,the medication delivery device or system may be in the form of a drugdelivery injection pen such as a pen-type injection device incorporatedwithin the housing of an analyte measurement system. Additionalinformation is provided in U.S. Pat. Nos. 5,536,249 and 5,925,021, thedisclosures of each of which are incorporated by reference herein intheir entirety.

Communication Interface

As discussed previously herein, an analyte measurement system accordingto the present disclosure can be configured to include a communicationinterface. In some embodiments, the communication interface includes areceiver and/or transmitter for communicating with a network and/oranother device, e.g., a medication delivery device and/or a patientmonitoring device, e.g., a continuous glucose monitoring device. In someembodiments, the communication interface is configured for communicationwith a health management system, such as the CoPilot™ system availablefrom Abbott Diabetes Care Inc., Alameda, Calif.

The communication interface can be configured for wired or wirelesscommunication, including, but not limited to, radio frequency (RF)communication (e.g., Radio-Frequency Identification (RFID), Zigbeecommunication protocols, WiFi, infrared, wireless Universal Serial Bus(USB), Ultra Wide Band (UWB), Bluetooth® communication protocols, andcellular communication, such as code division multiple access (CDMA) orGlobal System for Mobile communications (GSM).

In one embodiment, the communication interface is configured to includeone or more communication ports, e.g., physical ports or interfaces suchas a USB port, an RS-232 port, or any other suitable electricalconnection port to allow data communication between the analytemeasurement system and other external devices such as a computerterminal (for example, at a physician's office or in hospitalenvironment), an external medical device, such as an infusion device orincluding an insulin delivery device, or other devices that areconfigured for similar complementary data communication.

In one embodiment, the communication interface is configured forinfrared communication, Bluetooth® communication, or any other suitablewireless communication protocol to enable the analyte measurement systemto communicate with other devices such as infusion devices, analytemonitoring devices, computer terminals and/or networks, communicationenabled mobile telephones, personal digital assistants, or any othercommunication devices which the patient or user of the analytemeasurement system may use in conjunction therewith, in managing thetreatment of a health condition, such as diabetes.

In one embodiment, the communication interface is configured to providea connection for data transfer utilizing Internet Protocol (IP) througha cell phone network, Short Message Service (SMS), wireless connectionto a personal computer (PC) on a Local Area Network (LAN) which isconnected to the internet, or WiFi connection to the internet at a WiFihotspot.

In one embodiment, the analyte measurement system is configured towirelessly communicate with a server device via the communicationinterface, e.g., using a common standard such as 802.11 or Bluetooth® RFprotocol, or an IrDA infrared protocol. The server device could beanother portable device, such as a smart phone, Personal DigitalAssistant (PDA) or notebook computer; or a larger device such as adesktop computer, appliance, etc. In some embodiments, the server devicehas a display, such as a liquid crystal display (LCD), as well as aninput device, such as buttons, a keyboard, mouse or touch-screen. Withsuch an arrangement, the user can control the analyte measurement systemindirectly by interacting with the user interface(s) of the serverdevice, which in turn interacts with the analyte measurement systemacross a wireless link.

In some embodiments, the communication interface is configured toautomatically or semi-automatically communicate data stored in theanalyte measurement system, e.g., in an optional data storage unit, witha network or server device using one or more of the communicationprotocols and/or mechanisms described above.

Input Unit

As discussed previously herein, an analyte measurement system accordingto the present disclosure can be configured to include an input unitand/or input buttons coupled to the housing of the analyte measurementsystem and in communication with a controller unit and/or processor. Insome embodiments, the input unit includes one or more input buttonsand/or keys, wherein each input button and/or key is designated for aspecific task. Alternatively, or in addition, the input unit may includeone or more input buttons and/or keys that can be ‘soft buttons’ or‘soft keys’. In the case where one or more of the input buttons and/orkeys are ‘soft buttons’ or ‘soft keys’, these buttons and/or keys may beused for a variety of functions. The variety of functions may bedetermined based on the current mode of the analyte measurement system,and may be distinguishable to a user by the use of button instructionsshown on an optional display unit of the analyte measurement system. Yetanother input method may be a touch-sensitive display unit, as describedin greater detail below.

In addition, in some embodiments, the input unit is configured such thata user can operate the input unit to adjust time and/or dateinformation, as well as other features or settings associated with theoperation of an analyte measurement system.

Display Unit

As discussed previously herein, in some embodiments, an analytemeasurement system according to the present disclosure includes anoptional display unit or a port for coupling an optional display unit tothe analyte measurement system. The display unit is in communicationwith a control unit and/or processor and displays the analyte test stripsignals and/or results determined from the analyte test strip signalsincluding, for example, analyte concentration, rate of change of analyteconcentration, and/or the exceeding of a threshold analyte concentration(indicating, for example, hypo- or hyperglycemia).

The display unit can be a dot-matrix display, e.g., a dot-matrix LCDdisplay. In some embodiments, the display unit includes a liquid-crystaldisplay (LCD), thin film transistor liquid crystal display (TFT-LCD),plasma display, light-emitting diode (LED) display, seven-segmentdisplay, E-ink (electronic paper) display or combination of two or moreof the above. The display unit can be configured to provide, analphanumeric display, a graphical display, a video display, an audiodisplay, a vibratory output, or combinations thereof. The display can bea color display. In some embodiments, the display is a backlit display.

The display unit can also be configured to provide, for example,information related to a patient's current analyte concentration as wellas predictive analyte concentrations, such as trending information.

In some embodiments an input unit and a display unit are integrated intoa single unit, for example, the display unit can be configured as atouch sensitive display, e.g., a touch-screen display, where the usermay enter information or commands via the display area using, forexample, the user's finger, a stylus or any other suitable implement,and where, the touch sensitive display is configured as the userinterface in an icon driven environment, for example.

In some embodiments, the display unit does not include a screen designedto display results visually. Instead, in some embodiments the optionaldisplay unit is configured to communicate results audibly to a user ofthe analyte measurement system, e.g., via an integrated speaker, or viaseparate speakers through a headphone jack or Bluetooth® headset.

Expanding Menu Item for Improved Readability

In some embodiments, the display unit includes a graphical userinterface including a plurality of menu items, wherein the display unitis configured to provide clarification with respect to the meaning of amenu item based on a user's response speed with respect to a user inputfor the menu item. The menu item could take any of a variety of forms,e.g., text, icon, object or combination thereof.

In one embodiment, the graphical user interface includes a menu which inturn includes a plurality of selectable menu items. As a user navigatesthrough the menu, e.g., by highlighting or scrolling through individualmenu items, a menu item that is either unreadable or incomprehensible tothe user could cause the user to pause over a menu item to be selected.In one embodiment, a choice can be presented to the user, e.g., using adedicated physical button on an input unit, or a soft key on the menu,that offers further explanation of the item to be selected withoutactually selecting the item. For example, the graphical user interfacecan be configured such that after a pre-determined period of time a softkey offers an explanation of the menu item to be selected, e.g., bydisplaying a soft key with the word “MORE”, “ADDITIONAL INFORMATION”,“EXPAND”, “MAGNIFY”, “HELP” or a variation thereof displayed thereon.

The pre-determined period of time may be based on a fixed factory presetvalue, a value set by the user or a health care provider, or through anadaptive mechanism based on an analysis of the user's speed ofnavigation from past interactions with the graphical user interface. Inone embodiment, the pre-determined period of time is from about 5 toabout 20 seconds, e.g., from about 10 to about 15 seconds.

If the offer for clarification and/or additional information isselected, e.g., by pressing the softkey, then the menu item to beselected can be displayed in a “high emphasis” mode, e.g., where theitem is displayed as if a magnifying lens is held on top of the selecteditem. In some embodiments, additional emphasis of the menu item to beselected can be provided, e.g., by making the menu item change color,blink, or increase in size to a pre-determined maximum limit.

Support for on-Demand Analyte Determination Using an Analyte Sensor

In some embodiments, an analyte measurement system according to thepresent disclosure is further configured to receive analyteconcentration data and/or signals indicative of an analyte concentrationfrom an analyte sensor, e.g., an implanted or partially implantedanalyte sensor or a radio-frequency (RF)-powered measurement circuitcoupled to an implanted or partially implanted analyte sensor. In someembodiments, the analyte sensor is a self-powered analyte sensor. Ananalyte measurement system according to the present disclosure mayinclude software configured to analyze signals received from the analytesensor. Additional information related to self-powered analyte sensorsand methods of communicating therewith are provided in U.S. PatentApplication Publication No. 2010/0213057, the disclosure of which isincorporated by reference herein in its entirety.

Integrated Bar Code

In an embodiment, an analyte measurement system according to the presentdisclosure is integrated with a barcoding system. The barcoding systemmay be laser or LED based, and may be used for identification of analytetest strips, patient, health care professional, etc. For example, theanalyte measurement system may include a barcode reader disposed in thehousing. The housing would further require an internal circuitry and abarcode scan engine for processing of a scan. Additional examples ofsuch a bar coding system is provided in U.S. Pat. No. 7,077,328, whichhas been incorporated herein by reference in its entirety.

Anti-Microbial Thin Film Cover

In an embodiment, an analyte measurement system according to the presentdisclosure is provided with an anti-microbial thin film cover. A commonproblem with many analyte measurement systems is that the housingcracks, degrades, and generally wears down due to the harsh chemicalsthat are used to disinfect the analyte measurement system in hospitaland clinical environments. By placing an anti-microbial plastic filmover the analyte measurement system, the life-cycle of the system can beprolonged because the plastic film is subjected to the disinfectants,rather than the system housing itself. When the plastic film begins todegrade, it can be removed and replaced. The plastic film also adds anadditional layer of sterility to the system. The plastic film may betransparent, and applied over the display and/or user interface. Oneside of the plastic film would contain anti-microbial chemistry, whilethe back side of the plastic film would contain a thin layer ofadhesive.

Analytes

A variety of analytes can be detected and quantified using the disclosedanalyte measurement system. Analytes that may be determined include, forexample, acetyl choline, amylase, bilirubin, cholesterol, chorionicgonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA,fructosamine, glucose, glutamine, growth hormones, hormones, ketones(e.g., ketone bodies), lactate, oxygen, peroxide, prostate-specificantigen, prothrombin, RNA, thyroid stimulating hormone, and troponin.The concentration of drugs, such as, for example, antibiotics (e.g.,gentamicin, vancomycin, and the like), digitoxin, digoxin, drugs ofabuse, theophylline, and warfarin, may also be determined. Assayssuitable for determining the concentration of DNA and/or RNA aredisclosed in U.S. Pat. No. 6,281,006 and U.S. Pat. No. 6,638,716, thedisclosures of each of which are incorporated by reference herein intheir entirety.

CONCLUSION

The foregoing description of the subject matter of the presentdisclosure has been presented for purposes of illustration anddescription. It is not intended to be exhaustive or to limit theinvention to the precise form disclosed. Other modifications andvariations may be possible in light of the above teachings. Theembodiments were chosen and described in order to best explain theprinciples of the invention and its practical application, and tothereby enable others skilled in the art to best utilize the inventionin various embodiments and various modifications as are suited to theparticular use contemplated. It is intended that the appended claims beconstrued to include other alternative embodiments of the invention;including equivalent structures, components, methods, and means.

It is to be appreciated that the Detailed Description section, and notthe Summary and Abstract sections, is intended to be used to interpretthe claims. The Summary and Abstract sections may set forth one or more,but not all exemplary embodiments of the present invention ascontemplated by the inventor(s), and thus, are not intended to limit thepresent invention and the appended claims in any way.

1-18. (canceled)
 19. A method for determining the concentration ofanalyte in a sample using an analyte measurement system, the methodcomprising: positioning a replaceable strip port module within a stripport cavity of a housing of an analyte meter, wherein the analyte metercomprises the housing and electrical connections disposed with the stripport cavity within the housing, and the replaceable strip port modulecomprises: a module housing comprising an electrical interface aperturethat exposes an electrical interface within the module housing, and ananalyte test strip port disposed within the module housing andcomprising electrical contacts that couple to an analyte test strippositioned in the analyte test strip port, wherein the electricalinterface is disposed within the module housing and coupled to theanalyte test strip port, and wherein the electrical interface comprisesa plurality of electrical contacts that couple to electrical contacts ofthe analyte meter through the electrical interface aperture of themodule housing; contacting the sample to the analyte test strippositioned in the analyte test strip port of the replaceable strip portmodule; electrochemically determining the concentration of the analytein the blood sample using the analyte meter.
 20. The method according toclaim 19, wherein the concentration of glucose is determined.
 21. Themethod according to claim 19, wherein the sample is a blood sample. 22.The method according to claim 19, wherein the module housing fits withinan aperture in the housing of the analyte meter.
 23. The methodaccording to claim 22, wherein the module housing comprises externalalignment features to align the module housing within the aperture inthe housing of the analyte meter.
 24. The method according to claim 22,wherein the housing of the analyte meter comprises alignment features toalign the module housing within the aperture in the meter housing. 25.The method according to claim 19, wherein the module housing comprises afirst aperture that receives an analyte test strip.
 26. The methodaccording to claim 19, wherein the analyte test strip port is disposedwithin the module housing.
 27. The method according to claim 19, whereinthe electrical interface electrically couples to the analyte meterthrough the interface aperture of the module housing.
 28. The methodaccording to claim 26, wherein the analyte test strip port compriseselectrical contacts that couple to an analyte test strip positioned inthe first aperture of the module housing.
 29. The method according toclaim 19, wherein the electrical contacts of the electrical interfaceelectrically couple to the analyte test strip port and the analytemeter.
 30. The method according to claim 19, wherein positioning areplaceable strip port module in the housing of the analyte metercomprises electrically coupling the replaceable strip port module toelectrical connections within the housing of the analyte meter.
 31. Themethod according to claim 19, wherein positioning a replaceable stripport module in the housing of the analyte meter comprises: inserting thereplaceable strip port module into the housing of the analyte meter, andattaching the replaceable strip port module to the analyte meter byinserting an attachment feature in the housing of the analyte meter andthe replaceable strip port module.
 32. The method according to claim 31,wherein inserting the replaceable strip port module into the meteraligns the opening in the housing of the analyte meter with an openingin the replaceable strip port module, and attaching the replaceablestrip port module to the analyte meter further comprises inserting theattachment feature into the opening in the replaceable strip portmodule.
 33. The method according to claim 31, wherein inserting theattachment feature in the housing of the analyte meter and thereplaceable strip port module comprises: aligning an attachment aperturein the housing of the analyte meter with an attachment aperture in thereplaceable strip port module, and positioning the attachment featurewithin the attachment aperture of the housing of the analyte meter andthe attachment aperture of the second replaceable strip port.
 34. Themethod according to claim 19, wherein the interface aperture is on a topside of the module housing, and the module housing further comprises anopening for receiving an attachment feature on a bottom side of themodule housing, wherein the bottom side of the module housing isopposite from the top side.
 35. The method according to claim 19,wherein the housing of the analyte meter comprises an outer surface andthe replaceable strip port module comprises a cap having an outersurface, and wherein positioning the replaceable strip port module inthe analyte meter housing comprises aligning the outer surface of theanalyte meter housing with the outer surface of the cap so that theouter surfaces are flush.